list of anti-cancer drugs aproved by the fda _ pharmaknow
DESCRIPTION
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Drug Drug Trade Name Approved Use Manufacturer/DistributorApproval
Date
abarelix Plenaxis depot
For the palliativetreatment of men withadvanced symptomaticprostate cancer, inwhom LHRH agonisttherapy is notappropriate and whorefuse surgicalcastration, and have oneor more of the following:(1) risk of neurologicalcompromise due tometastases, (2) ureteralor bladder outletobstruction due to localencroachment ormetastatic disease, or (3)severe bone pain fromskeletal metastasespersisting on narcoticanalgesia
PraecisNov 252003
aldesleukin ProkineTreatment of adults withmetastatic melanoma
ChironJan 091998
Aldesleukin ProleukinTreatment of adults withmetastatic renal cellcarcinoma
Chiron CorpMay 051992
Alemtuzumab Campath
Accel. Approv. (clinicalbenefit not established)Campath is indicated forthe treatment of B-cellchronic lymphocyticleukemia (B-CLL) inpatients who have beentreated with alkylatingagents and who havefailed fludarabinetherapy.
Millennium and ILEXPartners, LP
May 072001
alitretinoin Panretin
Topical treatment ofcutaneous lesions inpatients withAIDS-related Kaposi’ssarcoma.
Ligand PharmaceuticalsFeb 021999
allopurinol Zyloprim
Patients with leukemia,lymphoma and solidtumor malignancies whoare receiving cancertherapy which causeselevations of serum andurinary uric acid levelsand who cannot tolerateoral therapy.
GlaxoSmithKlineMay 171996
Single agent palliativetreatment of patients
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oral therapy.
altretamine Hexalen
Single agent palliativetreatment of patientswith persistent orrecurrent ovarian cancerfollowing first-linetherapy with a cisplatinand/or alkylating agentbased combination.
US BioscienceDec 261990
amifostine Ethyol
To reduce thecumulative renal toxicityassociated with repeatedadministration ofcisplatin in patients withadvanced ovarian cancer
US BioscienceDec 081995
amifostine Ethyol
Accel. Approv. (clinicalbenefit not established)Reduction of platinumtoxicity in non-small celllung cancer
US BioscienceMar 151996
amifostine Ethyol
To reduce post-radiationxerostomia for head andneck cancer where theradiation port includes asubstantial portion of theparotid glands.
US BioscienceJun 241999
anakinra Kineret
pediatric Use section ofthe US product label andto fulfill PMC #3 toassess the safety andefficacy of anakinra inpediatric patients withjuvenile rheumatoidarthritis
AmgenDec 152006
anastrozole Arimidex
Accel. Approv. (clinicalbenefit not established)for the adjuvanttreatment ofpostmenopausal womenwith hormone receptorpositive early breastcancer
AstraZenecaSep 052002
anastrozole Arimidex
Conversion to regularapproval for theadjuvant treatment ofpostmenopausal womenwith hormone receptorpositive early breastcancer
AstraZenecaSep 162005
anastrozole Arimidex
Treatment of advancedbreast cancer inpostmenopausal womenwith disease progressionfollowing tamoxifentherapy
AstraZenecaPharmaceuticals
Dec 271995
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anastrozole Arimidexp pwith disease progressionfollowing tamoxifentherapy.
Pharmaceuticals 1995
anastrozole Arimidex
For first-line treatmentof postmenopausalwomen with hormonereceptor positive orhormone receptorunknown locallyadvanced or metastaticbreast cancer.
AstraZenecaPharmaceuticals
Sep 012000
arsenic trioxide Trisenox
Second line treatment ofrelapsed or refractoryAPL following ATRAplus an anthracycline.
Cell TherapeuticSep 252000
asparaginase ElsparTherapy of patients withacute lymphocyticleukemia
MerckJan 101978
Asparaginase Elspar
ELSPAR is indicated inthe therapy of patientswith acute lymphocyticleukemia. This agent isuseful primarily incombination with otherchemotherapeutic agentsin the induction ofremissions of the diseasein pediatric patients.
Merck & Co, IncAug 012002
azacitidine Vidaza
For use for the treatmentof patients with thefollowingmyelodysplasticsyndrome subtypes:refractory anemia orrefractory anemia withringed sideroblasts (ifaccompanied byneutropenia orthrombocytopenia andrequiring transfusions),refractory anemia withexcess blasts, refractoryanemia with excessblasts in transformation,and chronicmyelomonocyticleukemia
PharmionMay 192004
indicated for treatmentof patients with thefollowingmyelodysplasticsyndrome subtypes:refractory anemia orrefractory anemia withi d id bl (if
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azacitidine Vidaza
syndrome subtypes:refractory anemia orrefractory anemia withringed sideroblasts (ifaccompanied byneutropenia orthrombocytopenia orrequiring transfusions),refractory anemia withexcess blasts, refractoryanemia with excessblasts in transformation,and chronicmyelomonocyticleukemia.
PharmionJan 262007
BCG Live TICE BCG Organon Teknika CorpAug 211998
bevacizumab AvastinMetastatic coloncarcinoma
GenentechJun 202006
bevacizumab Avastin
FDA approved changedin the Avastin packageinsert regarding warningand dose andadministration forReversible PosteriorLeukoencephalopathySyndrome. Nasal septumperforation was alsoadded as a seriousadverse event.
GenentechSep 212006
bevacizumab Avastin
a first-line treatment ofpatients with locallyadvanced, metastatic orrecurrent non-small celllung cancer incombination withplatinum-basedchemotherapy
GenentechOct 112006
bevacuzimab Avastin
First-line treatment ofpatients with metastaticcarcinoma of the colonand rectum (incombination withintravenous5-fluorouracil-basedchemotherapy)
GenentechFeb 262004
bexarotene capsules Targretin
For the treatment by oralcapsule of cutaneousmanifestations ofcutaneous T-celllymphoma in patientswho are refractory to atleast one prior systemictherapy.
Ligand PharmaceuticalsDec 291999
For the topical treatment
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least one prior systemictherapy.
bexarotene gel Targretin
For the topical treatmentof cutaneousmanifestations ofcutaneous T-celllymphoma in patientswho are refractory to atleast one prior systemictherapy.
Ligand PharmaceuticalsJun 282000
bleomycin Blenoxane Bristol-Myers SquibbJul 311973
bleomycin Blenoxane
Sclerosing agent for thetreatment of malignantpleural effusion (MPE)and prevention ofrecurrent pleuraleffusions.
Bristol-Myers SquibbFeb 201996
bortezombi Velcade
for the treatment ofpatients with mantle celllymphoma who havereceived at least oneprior therapy
MillenniumDec 082006
bortezomib Velcade
Accel. Approv. (clinicalbenefit not established)for the treatment ofmultiple myelomapatients who havereceived at least twoprior therapies and havedemonstrated diseaseprogression on the lasttherapy
MilleniumMay 132003
bortezomib Velcade
Conversion to regularapproval for treatmentof multiple myelomapatients who havereceived as least oneprior therapy
MilleniumMar 252005
busulfan intravenous Busulfex
Use in combination withcyclophoshamide asconditioning regimenprior to allogeneichematopoieticprogenitor celltransplantation forchronic myelogenousleukemia.
Orphan Medical, IncFeb 041999
busulfan oral MyleranChronic MyelogenousLeukemia- palliativetherapy
GlaxoSmithKlineJun 261954
calusterone MethosarbPharmacia & UpjohnCompany
Feb 201973
Accel. Approv. (clinical
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calusterone MethosarbPharmacia & UpjohnCompany
Feb 201973
capecitabine Xeloda
Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof metastatic breastcancer resistant to bothpaclitaxel and ananthracycline containingchemotherapy regimenor resistant to paclitaxeland for whom furtheranthracycline therapymay be contraindicated,e.g., patients who havereceived cumulativedoses of 400 mg/m2 ofdoxorubicin ordoxorubicin equivalents
RocheApr 301998
capecitabine Xeloda
Initial therapy ofpatients with metastaticcolorectal carcinomawhen treatment withfluoropyrimidine therapyalone is preferred.Combinationchemotherapy hasshown a survival benefitcompared to 5-FU/LValone. A survival benefitover 5_FU/LV has notbeen demonstrated withXeloda monotherapy.
RocheApr 302001
capecitabine Xeloda
Conversion to regularapproval for treatment incombination withdocetaxel of patientswith metastatic breastcancer after failure ofprior anthracyclinecontainingchemotherapy
RocheSep 072001
capecitabine Xeloda
Adjuvant treatment inpatients with Dukes’ Ccolon cancer who haveundergone completeresection of the primarytumor when treatmentwith fluoropyrimidinetherapy alone ispreferred
RocheJun 152005
carboplatin Paraplatin
Palliative treatment ofpatients with ovariancarcinoma recurrentafter prior
Bristol-Myers SquibbMar 03
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carboplatin Paraplatin
patients with ovariancarcinoma recurrentafter priorchemotherapy, includingpatients who have beenpreviously treated withcisplatin.
Bristol-Myers SquibbMar 031989
carboplatin Paraplatin
Initial chemotherapy ofadvanced ovariancarcinoma incombination with otherapprovedchemotherapeuticagents.
Bristol-Myers SquibbJul 051991
carmustine BCNU, BiCNU Bristol-Myers SquibbMar 071977
carmustine Gliadel
Treatment of patientswith malignant gliomaundergoing primarysurgical resection
MGI PharmaFeb 252003
carmustine withPolifeprosan 20Implant
Gliadel Wafer
For use in addition tosurgery to prolongsurvival in patients withrecurrent glioblastomamultiforme who qualifyfor surgery.
Guilford PharmaceuticalsInc.
Sep 231996
celecoxib Celebrex
Accel. Approv. (clinicalbenefit not established)Reduction of polypnumber in patients withthe rare genetic disorderof familial adenomatouspolyposis.
SearleDec 231999
cetuximab Erbitux
Accel. Approv. (clinicalbenefit not established)for treatment ofEGFR-expressingmetastatic colorectalcarcinoma in patientswho are refractory toirinotecan-basedchemotherapy (incombination withirinotecan); as a singleagent, treatment ofEGFR-expressingmetastatic colorectalcarcinoma in patientswho are intolerant toirinotecan-basedchemotherapy
ImcloneFeb 122004
For use in combinationwith radiation therapy(RT) for the treatment oflocally or regionally
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cetuximab Erbitux
with radiation therapy(RT) for the treatment oflocally or regionallyadvanced squamous cellcarcinoma of the headand neck (SCCHN) or asa single agent for thetreatment of patientswith recurrent ormetastatic SCCHN forwhom priorplatinum-based therapyhas failed.
ImcloneMar 012006
chlorambucil Leukeran GlaxoSmithKlineMar 181957
cisplatin Platinol
Metastatic testicular-inestablished combinationtherapy with otherapprovedchemotherapeutic agentsin patients withmetastatic testiculartumors whoc havealready receivedappropriate surgicaland/or radiotherapeuticprocedures. Anestablished combinationtherapy consists ofPlatinol, Blenoxane andVelbam.
Bristol-Myers SquibbDec 191978
cisplatin Platinol
Metastatic ovariantumors - in establishedcombination therapywith other approvedchemotherapeuticagents: Ovarian-inestablished combinationtherapy with otherapprovedchemotherapeutic agentsin patients withmetastatic ovariantumors who havealready receivedappropriate surgicaland/or radiotherapeuticprocedures. Anestablished combinationconsists of Platinol andAdriamycin. Platinol, asa single agent, isindicated as secondarytherapy in patients withmetastatic ovarian
Bristol-Myers SquibbDec 191978
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indicated as secondarytherapy in patients withmetastatic ovariantumors refractory tostandard chemotherapywho have not previouslyreceived Platinoltherapy.
cisplatin Platinol
as a single agent forpatients with transitionalcell bladder cancerwhich is no longeramenable to localtreatments such assurgery and/orradiotherapy.
Bristol-Myers SquibbApr 221993
cladribine Leustatin, 2-CdATreatment of activehairy cell leukemia.
R.W. JohnsonPharmaceutical ResearchInstitute
Feb 261993
clofarabine Clolar
Accel. Approv. (clinicalbenefit not established)for the treatment ofpediatric patients 1 to 21years old with relapsedor refractory acutelymphoblastic leukemiaafter at least two priorregimens
GenzymeDec 282004
cyclophosphamide Cytoxan, Neosar Bristol-Myers SquibbNov 161959
cyclophosphamide Cytoxan Injection Bristol-Myers SquibbNov 161959
cyclophosphamide Cytoxan Injection Bristol-Myers SquibbApr 291987
cyclophosphamide Cytoxan Tablet Bristol-Myers SquibbApr 291987
cytarabine Cytosar-UPharmacia & UpjohnCompany
Jun 171969
cytarabine liposomal DepoCyt
Accel. Approv. (clinicalbenefit not established)Intrathecal therapy oflymphomatousmeningitis
Skye PharmaceuticalsApr 011999
dacarbazine DTIC-Dome BayerMay 271975
dactinomycin,actinomycin D
Cosmegen MerckFeb 041964
dactinomycin,actinomycin D
Cosmegan MerckDec 101964
provides for the use ofFragmin (dalteparinsodium injection) forextended treatment ofsymptomatic venous
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dalteparin sodium Fragmin
g ( psodium injection) forextended treatment ofsymptomatic venousthromboembolism (VTE)[proximal deep veinthrombosis (DVT)and/or pulmonaryembolism (PE)] toreduce the recurrence ofVTE in patients withcancer.
Pharmacia & UpjohnMay 012007
darbepoetin alfa Aranesp
for the treatment ofanemia associated withchronic renal failure,including patients ondialysis and patients noton dialysis, and for thetreatment of anemia inpatients withnon-myeloidmalignancies whereanemia is due to theeffect of concomitantlyadministeredchemotherapy.
AmgenMar 092007
darbepoetin alfa Aranesp AmgenApr 102007
Darbepoetin alfa AranespTreatment of anemiaassociated with chronicrenal failure.
Amgen, IncSep 172001
Darbepoetin alfa Aranesp
Aranesp is indicated forthe treatment of anemiain patients with non-myeloid malignancieswhere anemia is due tothe effect ofconcomitantlyadministeredchemotherapy.
Amgen, IncJul 192002
dasatinib SprycelChronic myelogenousleukemia
Bristol Myers SquibbJun 282006
daunorubicin liposomal DanuoXome
First line cytotoxictherapy for advanced,HIV related Kaposi’ssarcoma.
Nexstar, Inc.Apr 081996
daunorubicin,daunomycin
Daunorubicin
Leukemia/myelogenous/monocytic/erythroid ofadults/remissioninduction in acutelymphocytic leukemia ofchildren and adults.
Bedford LabsJan 301998
daunorubicin,daunomycin
Cerubidine
In combination withapproved anticancerdrugs for induction of
Wyeth AyerstMar 111987
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daunorubicin,daunomycin
Cerubidine
In combination withapproved anticancerdrugs for induction ofremission in adult ALL.
Wyeth AyerstMar 111987
decitabine Dacogen
for the treatment ofpatients withmyelodysplasticsyndromes (MDS)including previouslytreated and untreated, denovo and secondaryMDS of all French-American-Britishsubtypes (refractoryanemia, refractoryanemia with ringedsideroblasts, refractoryanemia with excessblasts, refractory anemiawith excess blasts intransformation, andchronic myelomonocyticleukemia) andintermediate-1,intermediate-2, andhigh-risk InternationalPrognostic ScoringSystem groups.
MGI PHARMA INCMay 052006
denileukin Ontak Seragen
Denileukin diftitox Ontak
Accel. Approv. (clinicalbenefit not established)treatment of patientswith persistent orrecurrent cutaneousT-cell lymphoma whosemalignant cells expressthe CD25 component ofthe IL-2 receptor
Seragen, IncFeb 051999
dexrazoxane Zinecard
Accel. Approv. (clinicalbenefit subsequentlyestablished) Preventionof cardiomyopathyassociated withdoxorubicinadministration
Pharmacia & UpjohnCompany
May 261995
dexrazoxane Zinecard
Conversion to regularapproval for reducingthe incidence andseverity ofcardiomyopathyassociated withdoxorubicinadministration in womenwith metastatic breastcancer who have Pharmacia & Upjohn Oct 31
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dexrazoxane Zinecard
administration in womenwith metastatic breastcancer who havereceived a cumulativedoxorubicin dose of 300mg/m2 and who willcontinue to receivedoxorubicin therapy tomaintain tumor control.It is not recommendedfor use with theinitiation of doxorubicintherapy.
Pharmacia & UpjohnCompany
Oct 312002
docetaxel Taxotere
Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof patients with locallyadvanced or metastaticbreast cancer who haveprogressed duringanthracycline-basedtherapy or have relapsedduringanthracycline-basedadjuvant therapy.
Aventis PharmaceuticalMay 141996
docetaxel Taxotere
Conversion to regularapproval - treatment oflocally advanced ormetastatic breast cancerwhich has progressedduringanthracycline-basedtreatment or relapsedduringanthracycline-basedadjuvant therapy.
Aventis PharmaceuticalJun 221998
docetaxel Taxotere
For locally advanced ormetastatic non-small celllung cancer after failureof prior platinum-basedchemotherapy.
Aventis PharmaceuticalDec 231999
docetaxel Taxotere
for use in combinationwith cisplatin for thetreatment of patientswith unresectable,locally advanced ormetastatic non-small celllung cancer who havenot previously receivedchemotherapy for thiscondition cisplatin forthe treatment of patientswith unresectable,locally advanced ormetastatic non-small cell
Aventis PharmaceuticalNov 272002
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with unresectable,locally advanced ormetastatic non-small celllung cancer who havenot previously receivedchemotherapy for thiscondition.
docetaxel Taxotere
For use in combinationwith prednisone as atreatment for patientswith androgenindependent (hormonerefractory) metastaticprostate cancer
Aventis PharmaceuticalMay 192004
docetaxel Taxotere
For use in combinationwith doxorubicin andcyclophosphamide forthe adjuvant treatmentof patients with operablenodepositive breastcancer
Aventis PharmaceuticalAug 182004
docetaxel Taxotere
for use in combinationwith cisplatin andfluorouracil for theinduction treatment ofpatients with inoperable,locally advancedsquamous cellcarcinoma of the headand neck.
Sanofi AventisOct 172006
doxorubicin Adriamycin PFS
For use in combinationwith cyclophosphamideas a component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer
PharmaciaMay 082003
doxorubicin Adriamycin, RubexPharmacia & UpjohnCompany
Aug 071974
doxorubicinAdriamycin PFSInjectionintravenousinjection
Antibiotic, antitumoragent.
Pharmacia & UpjohnCompany
Dec 231987
doxorubicin liposomal Doxil
Conversion to regularapproval for treatmentof patients with ovariancancer whose diseasehas progressed orrecurred afterplatinum-basedchemotherapy
AlzaJan 282005
Accel. Approv. (clinicalbenefit not established)Treatment of
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doxorubicin liposomal Doxil
Accel. Approv. (clinicalbenefit not established)Treatment ofAIDS-related Kaposi’ssarcoma in patients withdisease that hasprogressed on priorcombinationchemotherapy or inpatients who areintolerant to suchtherapy.
Sequus Pharmaceuticals,Inc.
Nov 171995
doxorubicin liposomal Doxil
Accel. Approv. (clinicalbenefit not established)Treatment of metastaticcarcinoma of the ovaryin patient with diseasethat is refractory to bothpaclitaxel and platinumbased regimens
Sequus Pharmaceuticals,Inc.
Jun 281999
DROMOSTANOLONEPROPIONATE
DROMOSTANOLONE Eli LillyOct 261961
DROMOSTANOLONEPROPIONATE
MASTERONEINJECTION
SYNTEXOct 081964
eculizumab Soliris
for the treatment ofparoxysmal nocturnalhemoglobinuria (PNH)to reduce hemolysis.
AlexionMar 162007
Elliott’s B Solution Elliott’s B Solution
Diluent for theintrathecaladministration ofmethotrexate sodiumand cytarabine for theprevention or treatmentof meningeal leukemiaor lymphocyticlymphoma.
Orphan Medical, IncSep 271996
epirubicin Ellence
A component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer.
Pharmacia & UpjohnCompany
Sep 151999
epirubicin hcl epirubicin hcl
as a component ofadjuvant therapy inpatients with evidenceof axillary node tumorinvolvement followingresection of primarybreast cancer.
MayneSep 152006
is indicated for thetreatment of anemiarelated to therapy with
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epoetin alfa Epogen/Procrit
is indicated for thetreatment of anemiarelated to therapy withzidovudine inHIV-infected patients.EPOGEN® is indicatedto elevate or maintainthe red blood cell level(as manifested by thehematocrit orhemoglobindeterminations) and todecrease the need fortransfusions in thesepatients. EPOGEN® isnot indicated for thetreatment of anemia inHIV-infected patientsdue to other factors suchas iron or folatedeficiencies, hemolysis,or gastrointestinalbleeding, which shouldbe managedappropriately.
AmgenMar 092007
Epoetin alfa epogen
EPOGENB is indicatedfor the treatment ofanemia in patients withnon-myeloidmalignancies whereanemia is due to theeffect of concomitantlyadministeredchemotherapy.EPOGEND is indicatedto decrease the need fortransfusions in patientswho will be receivingconcomitantchemotherapy for aminimum of 2 months.EPOGENB is notindicated for thetreatment of anemia incancer patients due toother factors such asiron or folatedeficiencies, hemolysisor gastrointestinalbleeding, which shouldbe managedappropriately.
Amgen, IncJul 261999
EPOGENB is indicatedfor the reatment ofanemia related totherapy with zidovudine
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Epoetin alfa epogen
EPOGENB is indicatedfor the reatment ofanemia related totherapy with zidovudinein HIV- infectedpatients. EPOGENB isindicated to elevate ormaintain the red bloodcell level (as manifestedby the hematocrit orhemoglobindeterminations) and todecrease the need fortransfusions in thesepatients. EPOGEND isnot indicated for thetreatment of anemia inHIV-infected patientsdue to other factors suchas iron or folatedeficiencies, hemolysisor gastrointestinalbleeding, which shouldbe managedappropriately.
Amgen, IncJul 261999
Epoetin alfa epogen
EPOGENB is indicatedfor the treatment ofanemic patients(hemoglobin > 10 to _<13 g/dL) scheduled toundergo elective,noncardiac, nonvascularsurgery to reduce theneed for allogeneicblood transfusions.
Amgen, IncJul 261999
Epoetin alfa epogen
EPOGEN is indicatedfor the treatment ofanemia associated withCRF, including patientson dialysis (ESRD) andpatients not on dialysis.
Amgen, InchJul 261999
erlotinib Tarceva
For treatment of locallyadvanced or metastaticNon Small-Cell LungCancer (NSCLC) afterfailure of at least oneprior chemotherapyregimen
OSINov 182004
erlotinib Tarceva
For use in combinationwith gemcitabine for thefirst-line treatment ofpatients with locallyadvanced, unresectableor metastatic pancreaticcancer
OSINov 022005
lli ti f t t Ph i & U j h D 24
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,or metastatic pancreaticcancer
estramustine Emcytpalliation of prostatecancer
Pharmacia & UpjohnCompany
Dec 241981
etoposide phosphate Etopophos
Management ofrefractory testiculartumors, in combinationwith other approvedchemotherapeuticagents.
Bristol-Myers SquibbMay 171996
etoposide phosphate Etopophos
Management of smallcell lung cancer,first-line, in combinationwith other approvedchemotherapeuticagents.
Bristol-Myers SquibbMay 171996
etoposide phosphate Etopophos
Management ofrefractory testiculartumors and small celllung cancer.
Bristol-Myers SquibbFeb 271998
etoposide, VP-16 Vepesid
Refractory testiculartumors-in combinationtherapy with otherapprovedchemotherapeutic agentsin patients withrefractory testiculartumors who havealready receivedappropriate surgical,chemotherapeutic andradiotherapeutictherapy.
Bristol-Myers SquibbNov 101983
etoposide, VP-16 VePesid
In combination withother approvedchemotherapeutic agentsas first line treatment inpatients with small celllung cancer.
Bristol-Myers SquibbDec 301986
etoposide, VP-16 Vepesid
In combination withother approvedchemotherapeutic agentsas first line treatment inpatients with small celllung cancer.
Bristol-Myers SquibbDec 301986
exemestane Aromasin
For adjuvant treatmentof postmenopausalwomen with estrogen-receptor positive earlybreast cancer who havereceived two to threeyears of tamoxifen andare switched toAROMASIN® for
PharmaciaOct 052005
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exemestane Aromasin years of tamoxifen andare switched toAROMASIN® forcompletion of a total offive consecutive years ofadjuvant hormonaltherapy
Pharmacia2005
exemestane Aromasin
Treatment of advancebreast cancer inpostmenopausal womenwhose disease hasprogressed followingtamoxifen therapy.
Pharmacia & UpjohnCompany
Oct 211999
fentanyl citrate Fentora
for the management ofbreakthrough pain inpatients with cancer whoare already receivingand who are tolerant toopioid therapy for theirunderlying persistentcancer pain.
CephalonSep 252006
Filgrastim Neupogen
Decrease incidence ofinfection in patients withnonmyeloidmalignancies
Amgen, IncFeb 201991
Filgrastim Neupogen
NEUPOGEN isindicated to decrease theincidence of infection‚as manifested by febrileneutropenia‚ in patientswith nonmyeloidmalignancies receivingmyelosuppressiveanticancer drugsassociated with asignificant incidence ofsevere neutropenia withfever.
Amgen, IncApr 021998
Filgrastim Neupogen
NEUPOGEN isindicated for reducingthe time to neutrophilrecovery and theduration of fever,following induction orconsolidationhemotherapy treatmentof adults with AML.
Amgen, IncApr 021998
Filgrastim Neupogen
NEUPOGEN isindicated to reduce theduration of neutropeniaand neutropenia-relatedclinical sequelae, eg,febrile neutropenia, inpatients withnonmyeloid
Amgen, IncApr 021998
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Filgrastim Neupogenfebrile neutropenia, inpatients withnonmyeloidmalignancies undergoingmyeloablativechemotherapy followedby marrowtransplantation.
Amgen, IncApr 021998
floxuridine(intraarterial)
FUDR RocheDec 181970
fludarabine Fludara
Palliative treatment ofpatients with B-celllymphocytic leukemia(CLL) who have notresponded or haveprogressed duringtreatment with at leastone standard alkylatingagent containingregimen.
Berlex Laboratories Inc.Apr 181991
fluorouracil, 5-FU Adrucilprolong survival incombination withleucovorin
ICN Puerto RicoApr 251962
fulvestrant Faslodex
the treatment ofhormone receptor-positive metastaticbreast cancer inpostmenopausal womenwith disease progressionfollowing antiestrogentherapy
IPRApr 252002
gefitinib Iressa
Accel. Approv. (clinicalbenefit not established )as monotherapy for thetreatment of patientswith locally advanced ormetastatic non-small celllung cancer after failureof both platinum-basedand docetaxelchemotherapies
AstraZencaMay 052003
gemcitabine Gemzar
Treatment of patientswith locally advanced(nonresectable stage IIor III) or metastatic(stage IV)adenocarcinoma of thepancreas. Indicated forfirst-line treatment andfor patients previouslytreated with a5-fluorouracil-containingregimen.
Eli LillyMay 151996
For use in combinationith i l ti f th
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gregimen.
gemcitabine Gemzar
For use in combinationwith cisplatin for thefirst-line treatment ofpatients with inoperable,locally advanced (StageIIIA or IIIB) ormetastatic (Stage IV)non-small cell lungcancer.
Eli LillyAug 251998
gemcitabine hcl Gemzar Ovarian cancer LillyJul 142006
gemicitabine Gemzar
For use in combinationwith paclitaxel for thefirst-line treatment ofpatients with metastaticbreast cancer afterfailure of prioranthracycline-containingadjuvant chemotherapy,unless anthracyclineswere clinicallycontraindicated
LillyMay 192004
gemtuzumabozogamicin
Mylotarg
Accel. Approv. (clinicalbenefit not established)Treatment of CD33positive acute myeloidleukemia in patients infirst relapse who are 60years of age or older andwho are not consideredcandidates for cytotoxicchemotherapy.
Wyeth AyerstMay 172000
goserelin acetate ZoladexAstraZenecaPharmaceuticals
Dec 181995
goserelin acetate Zoladex Implant
Palliative treatment ofadvanced breast cancerin pre- andperimenopausal women.
AstraZenecaPharmaceuticals
Dec 181995
histrelin acetate Histrelin implantFor the palliativetreatment of advancedprostate cancer
ValeraOct 122004
hydroxyurea Hydrea Bristol-Myers SquibbDec 071967
hydroxyurea HydreaDecrease need fortransfusions in sickle cellanemia
Bristol-Myers SquibbFeb 251998
Ibritumomab Tiuxetan Zevalin
Accel. Approv. (clinicalbenefit not established)treatment of patientswith relapsed orrefractory low-grade,follicular, or transformedB cell non Hodgkin’s
IDEC PharmaceuticalsCorp
Feb 192002
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Ibritumomab Tiuxetan Zevalin
prefractory low-grade,follicular, or transformedB-cell non-Hodgkin’slymphoma, includingpatients with Rituximabrefractory follicularnon-Hodgkin’slymphoma.
IDEC PharmaceuticalsCorp
Feb 192002
idarubicin Idamycin
For use in combinationwith other approvedantileukemic drugs forthe treatment of acutemyeloid leukemia(AML) in adults.
Adria LaboratoriesSep 271990
idarubicin Idamycin
In combination withother approvedantileukemic drugs forthe treatment of acutenon-lymphocyticleukemia in adults.
Pharmacia & UpjohnCompany
Feb 171997
ifosfamide IFEX
Third line chemotherapyof germ cell testicularcancer when used incombination with certainother approvedantineoplastic agents.
Bristol-Myers SquibbDec 301988
imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)Initial therapy of chronicmyelogenous leukemia
NovartisMay 102001
imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)metastatic orunresectable malignantgastrointestinal stromaltumors
NovartisFeb 012002
Imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)Treatment of patientswith Kit (CD117)positive unresectableand/or metastaticmalignantgastrointestinal stromaltumors (GIST).
NovartisFeb 012002
imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)Initial treatment ofnewly diagnosed Ph+chronic myelogenousleukemia (CML).
NovartisDec 202002
Accel. Approv. (clinicalbenefit not established)for treatment of newly
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imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)for treatment of newlydiagnosed adult patientswith Philadelphiachromosome positivechronic myeloidleukemia (CML) inchronic phase.Follow-up is limited.Gleevec is also indicatedfor the treatment ofpatients withPhiladelphiachromosome positivechronic myeloidleukemia (CML) in blastcrisis, accelerated phase,or in chronic phase afterfailure ofinterferon-alpha therapy.There are no controlledtrials demonstrating aclinical benefit, such asimprovement in disease-related symptoms orincreased survival inpatients with CML blastcrisis, accelerated phaseor chronic phase afterfailure of alphainterferon. Gleevec isalso indicated for thetreatment of patientswith Kit (CD117)positive unresectableand/or metastaticmalignantgastrointestinal stromaltumors (GIST)
NovartisApr 182003
imatinib mesylate Gleevec
Accel. Approv. (clinicalbenefit not established)Treatment of pediatricpatients with Ph+chronic phase CMLwhose disease hasrecurred after stem celltransplant or who areresistant to interferonalpha therapy.
NovartisMay 202003
imatinib mesylate Gleevec
Conversion to regularapproval for treatmentof patients withPhiladelphiachromosome positivechronic myeloid Novartis
Dec 08
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imatinib mesylate Gleevec
pPhiladelphiachromosome positivechronic myeloidleukemia (CML) in blastcrisis, accelerated phase,or in chronic phase afterfailure ofinterferon-alpha therapy
NovartisDec 082003
imatinib mesylate Gleevec
for the treatment ofpediatric patients withnewly diagnosedPhiladelphiachromosome positivechronic myelogenousleukemia (Ph+ CML).
NovartisSep 272006
imatinib mesylate Gleevecsingle agent for thetreatment of multipleindications
NovartisOct 192006
interferon alfa 2a Roferon ATreatment of patientswith hairy cell leukemia
RocheJun 041986
interferon alfa 2a Roferon A
Chronic phase,Philadelphiachromosome positivechronic myelogenousleukemia (CML)patients who areminimally pretreated(within 1 year ofdiagnosis)
RocheOct 191995
Interferon alfa-2a Roferon-A Hoffmann-La Roche IncNov 011996
Interferon alfa-2b Intron A
Interferon alfa-2b,recombinant forInjection is indicated forthe treatment of patients18 years of age or olderwith hairy cell leukemia.
Schering CorpJun 041986
Interferon alfa-2b Intron A
Interferon alfa-2b,recombinant forInjection is indicated forintralesional treatmentof selected patients 18years of age or olderwith condylomataacuminata involvingexternal surfaces of thegenital and perianalareas.
Schering CorpJun 061988
Interferon alfa-2b,recombinant forinjection is indicated forthe treatment of selectedpatients 18 years of ageor older with
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Interferon alfa-2b Intron A
the treatment of selectedpatients 18 years of ageor older withAIDS-related Kaposi’sSarcoma. The likelihoodof response to INTRONA therapy is greater inpatients who are withoutsystemic symptoms, whohave limitedlymphadenopathy andwho have a relativelyintact immune system asindicated by total CD4count.
Schering CorpNov 211988
Interferon alfa-2b Intron A
Interferon alfa-2b,recombinant forinjection is indicated asadjuvant to surgicaltreatment in patients 18years of age or olderwith malignantmelanoma who are freeof disease but at highrisk for systemicrecurrence within 56days of surgery.
Schering CorpDec 051995
Interferon alfa-2b Intron A
Interferon alfa-2b,recombinant forInjection is indicated forthe initial treatment ofclinically aggressivefollicular non-Hodgkin’sLymphoma inconjunction withanthracycline-containingcombinationchemotherapy inpatients 18 years of ageor older.
Schering CorpNov 061997
Interferon alfa-2b Intron A Intron A Schering CorpJun 212002
irinotecan Camptosar
Accel. Approv. (clinicalbenefit subsequentlyestablished) Treatmentof patients withmetastatic carcinoma ofthe colon or rectumwhose disease hasrecurred or progressedfollowing 5-FU-basedtherapy.
Pharmacia & UpjohnCompany
Jun 141996
Conversion to regularapproval - treatment ofmetastatic carcinoma of
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irinotecan Camptosar
Conversion to regularapproval - treatment ofmetastatic carcinoma ofthe colon or rectumwhose disease hasrecurred or progressedfollowing 5-FU-basedtherapy.
Pharmacia & UpjohnCompany
Oct 221998
irinotecan Camptosar
For first line treatment ncombination with5-FU/leucovorin ofmetastatic carcinoma ofthe colon or rectum.
Pharmacia & UpjohnCompany
Apr 202000
lapatinib ditosylate Tykerb
for use in combinationwith capecitabine for thetreatment of patientswith advanced ormetastatic breast cancerwhose tumorsoverexpress HER2(ErbB2) and who havereceived prior therapyincluding ananthracycline, a taxane,and trastuzumab.
SmithKline BeechamMar 132007
lapatinib ditosylate Tykerb SmithKline BeechamApr 272007
lenalidomide Revlimid Multiple myeloma CelegeneJun 292006
lenalidomide Revlimid
for the treatment ofpatients withtransfusion-dependentanemia due to Low- orIntermediate-1-riskmyelodysplasticsyndromes associatedwith a deletion 5qcytogenetic abnormalitywith or withoutadditional cytogeneticabnormalities
CelgeneDec 272005
letrozole FemaraTreatment of advancedbreast cancer inpostmenopausal women.
NovartisJul 251997
letrozole Femara
First-line treatment ofpostmenopausal womenwith hormone receptorpositive or hormonereceptor unknownlocally advanced ormetastatic breast cancer.
NovartisJan 102001
letrozole Femara NovartisJan 172003
Accel. Approv. (clinical
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letrozole Femara NovartisJan 172003
letrozole Femara
Accel. Approv. (clinicalbenefit not established)for the extendedadjuvant treatment ofearly breast cancer inpostmenopausal womenwho have received fiveyears of adjuvanttamoxifen therapy.
NovartisOct 292004
leucovorinWellcovorin,Leucovorin
Leucovorin calcium isindicated fro use incombination with5-fluorouracil to prolongsurvival in the palliativetreatment of patientswith advancedcolorectal cancer.
Immunex CorporationJun 201952
leucovorin Leucovorin Immunex CorporationJan 301987
leucovorin Leucovorin Immunex CorporationJan 301987
leucovorin Leucovorin Immunex CorporationAug 311988
leucovorin Leucovorin
In combination withfluorouracil to prolongsurvival in the palliativetreatment of patientswith advancedcolorectal cancer.
Lederle LaboratoriesDec 121991
Leuprolide Acetate Eligardpalliative treatment ofadvanced prostatecancer.
QLT USAJan 232002
levamisole Ergamisol
Adjuvant treatment incombination with5-fluorouracil aftersurgical resection inpatients with Dukes’Stage C colon cancer.
Janssen ResearchFoundation
Jun 181990
lomustine, CCNU CeeBU Bristol-Myers SquibbAug 041976
meclorethamine,nitrogen mustard
Mustargen MerckMar 151949
megestrol acetate Megace Bristol-Myers SquibbAug 181971
melphalan, L-PAM Alkeran GlaxoSmithKlineJan 171964
melphalan, L-PAM Alkeran
Systemic administrationfor palliative treatmentof patients with multiplemyeloma for whom oraltherapy is notappropriate.
GlaxoSmithKlineNov 181992
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melphalan, L-PAM Alkeranmyeloma for whom oraltherapy is notappropriate.
GlaxoSmithKline1992
mercaptopurine, 6-MP Purinethol GlaxoSmithKlineSep 111953
mesna MesnexPrevention ofifosfamide-inducedhemorrhagic cystitis
Asta MedicaDec 301988
mesna Mesnex tabsReducing the incidenceof ifosfamide-inducedhemorrhagic cystitis
BaxterMar 212002
methotrexate Methotrexate Lederle LaboratoriesDec 071953
methotrexate Methotrexate Lederle LaboratoriesAug 101959
methotrexate Methotrexate Lederle LaboratoriesNov 011971
methotrexate Methotrexate Lederle LaboratoriesNov 011971
methotrexate Methotrexate osteosarcoma Lederle LaboratoriesApr 071988
methotrexate Methotrexate Lederle LaboratoriesOct 311988
methoxsalen Uvadex
For the use of UVADEXwith the UVARPhotopheresis System inthe palliative treatmentof the skinmanifestations ofcutaneous T-celllymphoma (CTCL) thatis unresponsive to otherforms of treatment.
TherakosFeb 251999
mitomycin C Mutamycin Bristol-Myers SquibbMay 281974
mitomycin C Mitozytrex
therapy of disseminatedadenocarcinoma of thestomach or pancreas inproven combinationswith other approvedchemotherapeutic agentsand as palliativetreatment when othermodalities have failed.
SupergenNov 142002
mitotane Lysodren Bristol-Myers SquibbJul 081970
mitoxantrone Novantrone
For use in combinationwith corticosteroids asinitial chemotherapy forthe treatment of patientswith pain related toadvanced hormone-refractory prostate
Immunex CorporationNov 131996
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with pain related toadvanced hormone-refractory prostatecancer.
p1996
mitoxantrone Novantrone
For use with otherapproved drugs in theinitial therapy for acutenonlymphocyticleukemia (ANLL) inadults.
Lederle LaboratoriesDec 231987
nandrolonephenpropionate
Durabolin-50 OrganonOct 301959
nelarabine Arranon
Accel. Approv. (clinicalbenefit not established)for the treatment ofpatients with T-cellacute lymphoblasticleukemia and T-celllymphoblasticlymphoma whosedisease has notresponded to or hasrelapsed followingtreatment with at leasttwo chemotherapyregimens
GlaxoSmithKlineOct 282005
Nofetumomab VerlumaBoehringer IngelheimPharma KG (formerly Dr.Karl Thomae GmbH)
Aug 201996
Oprelvekin Neumega
Prevention of severethrombocytopeniafollowingmyelosuppressivechemotherapy
Genetics Institute, IncNov 251997
Oprelvekin Neumega Genetics Institute, IncSep 182002
Oprelvekin Neumega
Neumega is indicated forthe prevention of severethrombocytopenia andthe reduction of theneed for platelettransfusions followingmyelosuppressivechemotherapy in adultpatients withnonmyeloidmalignancies who are athigh risk of severethrombocytopenia.
Genetics Institute, IncSep 182002
oprelvekin Neumega
warnings regardingophthalmologic andventricular arrhythmiasadverse events havebeen added to theoprelvekin (Neumega)
WyethSep 132006
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oprelvekin Neumegay
adverse events havebeen added to theoprelvekin (Neumega)label
WyethSep 132006
oxaliplatin Eloxatin
Accel. Approv. (clinicalbenefit not established)in combination withinfusional 5-FU/LV, isindicated for thetreatment of patientswith metastaticcarcinoma of the colonor rectum whose diseasehas recurred orprogressed during orwithin 6 months ofcompletion of first linetherapy with thecombination of bolus5-FU/LV and irinotecan.
Sanofi SynthelaboAug 092002
oxaliplatin Eloxatin
Conversion to regularapproval for use incombination withinfusional 5-Fluorouracil(5-FU) and Leucovorin(LV) for the treatment ofpatients previouslyuntreated for advancedcolorectal cancer
Sanofi SynthelaboJan 092004
oxaliplatin Eloxatin
for use in combinationwith infusional 5-FU/LV,for the adjuvanttreatment of stage IIIcolon cancer patientswho have undergonecomplete resection ofthe primary tumor
Sanofi SynthelaboNov 042004
paclitaxel Abraxane
for the treatment ofbreast cancer afterfailure of combinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded ananthracycline unlessclinicallycontraindicated.
AbraxisFeb 152007
paclitaxel Paxene
treatment of advancedAIDS-related Kaposi’ssarcoma after failure offirst line or subsequentsystemic chemotherapy
Baker NortonPharmaceuticals, Inc
Dec 241997
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paclitaxel PaxeneS e ed pos s
sarcoma after failure offirst line or subsequentsystemic chemotherapy
Baker NortonPharmaceuticals, Inc
Dec 241997
paclitaxel Taxol
Treatment of patientswith metastaticcarcinoma of the ovaryafter failure of first-lineor subsequentchemotherapy.
Bristol-Myers SquibbDec 291992
paclitaxel Taxol
Treatment of breastcancer after failure ofcombinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded ananthracycline unlessclinicallycontraindicated.
Bristol-Myers SquibbApr 131994
paclitaxel Taxol
New dosing regimen forpatients who have failedinitial or subsequentchemotherapy formetastatic carcinoma ofthe ovary
Bristol-Myers SquibbJun 221994
paclitaxel Taxolsecond line therapy forAIDS related Kaposi’ssarcoma.
Bristol-Myers SquibbAug 041997
paclitaxel Taxol
For first-line therapy forthe treatment ofadvanced carcinoma ofthe ovary in combinationwith cisplatin.
Bristol-Myers SquibbApr 091998
paclitaxel Taxol
for use in combinationwith cisplatin, for thefirst-line treatment ofnon-small cell lungcancer in patients whoare not candidates forpotentially curativesurgery and/or radiationtherapy.
Bristol-Myers SquibbJun 301998
paclitaxel Taxol
For the adjuvanttreatment ofnode-positive breastcancer administeredsequentially to standarddoxorubicin-containingcombination therapy.
Bristol-Myers SquibbOct 251999
paclitaxel TaxolFirst line ovarian cancerwith 3 hour infusion.
Bristol-Myers SquibbJun 202000
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combination therapy.
paclitaxel TaxolFirst line ovarian cancerwith 3 hour infusion.
Bristol-Myers SquibbJun 202000
paclitaxelprotein-bound particles
Abraxane
For the treatment ofbreast cancer afterfailure of combinationchemotherapy formetastatic disease orrelapse within 6 monthsof adjuvantchemotherapy. Priortherapy should haveincluded an anthracylineunless clinicallycontraindicated
AM BioscienceJan 072005
palifermin Kepivance
Decrease the incidenceand duration of severeoral mucositis in patientswith hematologicmalignancies receivingmyelotoxic therapyrequiring hematopoeticstem cell support
AmgenDec 152004
pamidronate Aredia
Treatment of osteolyticbone metastases ofbreast cancer inconjunction withstandard antineoplastictherapy.
NovartisSep 221998
panitumumab Vectibixto treat metastaticcolorectal carcinoma
AmgenSep 272006
pegademaseAdagen (PegademaseBovine)
Enzyme replacementtherapy for patients withsevere combinedimmunodeficiency asaresult of adenosinedeaminase deficiency.
EnzonMar 211990
pegaspargase OncasparAcute lymphoblasticleukemia
EnzonJul 242006
pegaspargase Oncaspar
Acute lymphocyticleukemia inL-asparaginasehypersensitive patients
Enzon, IncFeb 011994
Pegfilgrastim Neulasta
Neulasta is indicated todecrease the incidenceof infection, asmanifested by febrileneutropenia, in patientswith non-myeloidmalignancies receivingmyelosuppressiveanti-cancer drugsassociated with aclinically significanti id f f b il
Amgen, IncJan 312002
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anti-cancer drugsassociated with aclinically significantincidence of febrileneutropenia.
Peginterferon alfa-2b PegIntrontrade name fromPEG-Intron to PegIntron
ScheringDec 222006
pemetrexed disodium Alimta
For use in the treatmentof patients withmalignant pleuralmesothelioma whosedisease is eitherunresectable or who areotherwise not candidatesfor curative surgery
LillyFeb 042004
pemetrexed disodium Alimta
Accel. Approv. (clinicalbenefit not established)as a single agent for thetreatment of patientswith locally advanced ormetastatic non-smalllung cancer after priorchemotherapy
LillyAug 192004
pentostatin Nipent
Single agent treatmentfor adult patients withalpha interferonrefractory hairy cellleukemia.
Parke-DavisPharmaceutical Co.
Oct 111991
pentostatin Nipent
Single-agent treatmentfor untreated hairy cellleukemia patients withactive disease as definedby clinically significantanemia, neutropenia,thrombocytopenia, ordisease-relatedsymptoms. (Supplementfor front -line therapy.)
Parke-DavisPharmaceutical Co.
Sep 291993
pipobroman Vercyte Abbott LabsJul 011966
plicamycin,mithramycin
Mithracin Pfizer LabsMay 051970
porfimer sodium Photofrin
For the ablation ofhigh-grade dysplasia inBarrett’s esophaguspatients who do notundergo esophagectomy
Axcan ScandipharmAug 012003
porfimer sodium Photofrin
For use in photodynamictherapy (PDT) forpalliation of patientswith completelyobstructing esophagealcancer, or patients withpartially obstructingesophageal cancer who
QLT Phototherapeutics Inc.Dec 271995
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porfimer sodium Photofring p g
cancer, or patients withpartially obstructingesophageal cancer whocannot be satisfactorilytreated with ND-YAGlaser therapy.
QLT Phototherapeutics Inc.Dec 271995
porfimer sodium Photofrin
For use in photodynamictherapy for treatment ofmicroinvasiveendobronchial nonsmallcell lung cancer inpatients for whomsurgery and radiotherapyare not indicated.
QLT Phototherapeutics Inc.Jan 091998
porfimer sodium Photofrin
For use in photodynamictherapy (PDT) forreduction of obstructionand palliation ofsymptoms in patientswith completely orpartially obstructingendobroncial nonsmallcell lung cancer(NSCLC).
QLT Phototherapeutics Inc.Dec 221998
procarbazine Matulane Sigma Tau PharmsJul 221969
quinacrine Atabrine Abbott LabsDec 071964
Rasburicase Elitek
ELITEK is indicated forthe initial managementof plasma uric acidlevels in pediatricpatients with leukemia,lymphoma, and solidtumor malignancies whoare receiving anti-cancertherapy expected toresult in tumor lysis andsubsequent elevation ofplasma uric acid.
Sanofi-Synthelabo, IncJul 122002
rituximab Rituxan
for the first-linetreatment of patientswith low grade orfollicular, CD20-positiveB-cell non-Hodgkin’slymphoma.
GenentechSep 292006
rituximab Rituxan
for the first-linetreatment of patientswith low grade orfollicular, CD20-positiveB-cell non-Hodgkin’slymphoma.
GenentechSep 292006
Treatment of patientswith relapsed or
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lymphoma.
Rituximab Rituxan
Treatment of patientswith relapsed orrefractory low-grade orfollicular B-cellnon-Hodgkin’slymphoma
Genentech, IncNov 261997
Rituximab Rituxannon-Hodgkin’slymphoma
Genentech, IncFeb 102006
sargramostim Leukine
Acceleration of myeloidrecovery followingautologous bone marrowtransplant in patientswith non-Hodgkin’slymphoma, acutelymphocytic leukemia,or Hodgkin’s disease
BerlexMar 051991
Sargramostim Prokine Immunex CorpNov 071996
sorafenib NexavarFor the treatment ofpatients with advancedrenal cell carcinoma
BayerDec 202005
streptozocin Zanosar Antineoplastic agent.Pharmacia & UpjohnCompany
May 071982
sunitinib Sutent
for the treatment ofgastrointestinal stromaltumor after diseaseprogression on orintolerance to imatinibmesylate; for thetreatment of advancedrenal cell carcinoma.
CP PharmaceuticalsFeb 022007
sunitinib maleate Sutent
treatment ofgastrointestinal stromaltumor after diseaseprogression on orintolerance to imatinibmesylate
PfizerJan 262006
sunitinib maleate Sutent
Accel. Approv. (clinicalbenefit not established)for the treatment ofadvanced renal cellcarcinoma. Approval foradvanced renal cellcarcinoma is based onpartial response ratesand duration ofresponses. There are norandomized trials ofSUTENT demonstratingclinical benefit such asincreased survival orimprovement in disease-related symptoms in
l ll i
PfizerJan 262006
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increased survival orimprovement in disease-related symptoms inrenal cell carcinoma.
talc Sclerosol
For the prevention of therecurrence of malignantpleural effusion insymptomatic patients.
BryanDec 241997
tamoxifen NolvadexAstraZenecaPharmaceuticals
Dec 301977
tamoxifen Nolvadex
As a single agent todelay breast cancerrecurrence followingtotal mastectomy andaxillary dissection inpostmenopausal womenwith breast cancer(T1-3, N1, M0)
AstraZenecaPharmaceuticals
Dec 031986
tamoxifen Nolvadex
For use inpremenopausal womenwith metastatic breastcancer as an alternativeto oophorectomy orovarian irradiation
AstraZenecaPharmaceuticals
Mar 161989
tamoxifen Nolvadex
For use in women withaxillary node-negativebreast cancer adjuvanttherapy.
AstraZenecaPharmaceuticals
Jun 211990
tamoxifen NolvadexMetastatic breast cancerin men.
AstraZenecaPharmaceuticals
Apr 011993
tamoxifen Nolvadex
Equal bioavailability ofa 20 mg Nolvadex tablettaken once a day to a 10mg Nolvadex tablettaken twice a day.
AstraZenecaPharmaceuticals
Mar 211994
tamoxifen Nolvadex
to reduce the incidenceof breast cancer inwomen at high risk forbreast cancer
AstraZenecaPharmaceuticals
Oct 291998
tamoxifen Nolvadex
In women with DCIS,following breast surgeryand radiation, Nolvadexis indicated to reducethe risk of invasivebreast cancer.
AstraZenecaPharmaceuticals
Jun 292000
temozolomide Temodar
Accel. Approv. (clinicalbenefit not established)Treatment of adultpatients with refractoryanaplastic astrocytoma,i.e., patients at firstrelapse with diseaseprogression on anitrosourea and
b i t i i
ScheringAug 111999
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relapse with diseaseprogression on anitrosourea andprocarbazine containingregimen
temozolomide Temodar
Conversion to regularapproval for thetreatment of patientswith newly diagnosedhigh grade gliomasconcomitantly withradiotherapy and then asadjuvant treatment
ScheringMar 152005
teniposide, VM-26 Vumon
In combination withother approvedanticancer agents forinduction therapy inpatients with refractorychildhood acutelymphoblastic leukemia(all).
Bristol-Myers SquibbJul 141992
testolactone Teslac Bristol-Myers SquibbJun 031969
testolactone Teslac Bristol-Myers SquibbMay 271970
thalidomide Thalomid Multiple myeloma CelgeneMay 262006
thioguanine, 6-TG Thioguanine GlaxoSmithKlineJan 181966
thiotepa Thioplex Immunex CorporationMar 091959
thiotepa Thioplex Immunex CorporationDec 221994
thiotepa Thioplex Lederle LaboratoriesAug 151990
topotecan Hycamtin
Treatment of patientswith metastaticcarcinoma of the ovaryafter failure of initial orsubsequentchemotherapy.
GlaxoSmithKlineMay 281996
topotecan Hycamtin
Treatment of small celllung cancer sensitivedisease after failure offirst-line chemotherapy.In clinical studiessubmitted to supportapproval, sensitivedisease was defined asdisease responding tochemotherapy butsubsequently progressingat least 60 days (in thephase 3 study) or at least90 d (i h h 2
GlaxoSmithKlineNov 301998
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subsequently progressingat least 60 days (in thephase 3 study) or at least90 days (in the phase 2studies) afterchemotherapy
topotecan hcl Hycamtin Cervical carcinoma GlaxoSmithKlineJun 142006
toremifene FarestonTreatment of advancedbreast cancer inpostmenopausal women.
Orion Corp.May 291997
Tositumomab Bexxar
Accel. Approv. (clinicalbenefit not established)Treatment of patientswith CD20 positive,follicular, non-Hodgkin’slymphoma, with andwithout transformation,whose disease isrefractory to Rituximaband has relapsedfollowing chemotherapy
Corixa CorporationJun 272003
Tositumomab/I-131tositumomab
Bexxar
Expand the indication toinclude patients withrelapsed or refractorylow grade folliculartransformedCD20-positivenon-Hodgkin’slymphoma who have notreceived rituximab
GlaxoSmithKlineDec 222004
trastuzumab HerceptinEarly Stage BreastCancer After PrimaryTherapy
GenentechNov 162006
Trastuzumab Herceptin
HERCEPTIN as a singleagent is indicated for thetreatment of patientswith metastatic breastcancer whose tumorsoverexpress the HER2protein and who havereceived one or morechemotherapy regimensfor their metastaticdisease.
Genentech, IncSep 251998
Trastuzumab Herceptin
Herceptin incombination withpaclitaxel is indicatedfor treatment of patientswith metastatic breastcancer whose tumorsoverexpress the HER-2protein and had notreceived chemotherapyfor their metastatic
Genentech, IncFeb 092000
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protein and had notreceived chemotherapyfor their metastaticdisease
Trastuzumab Herceptin Genentech, IncAug 282002
Trastuzumab Herceptin Genentech, IncAug 282002
tretinoin, ATRA Vesanoid
Induction of remission inpatients with acutepromyelocytic leukemia(APL) who arerefractory to or unableto tolerate anthracyclinebased cytotoxicchemotherapeuticregimens.
RocheNov 221995
Uracil MustardUracil MustardCapsules
Roberts LabsSep 131962
valrubicin Valstar
For intravesical therapyof BCG-refractorycarcinoma in situ (CIS)of the urinary bladder inpatients for whomimmediate cystectomywould be associatedwith unacceptablemorbidity or mortality.
Anthra –> MedevaSep 251998
vinblastine Velban Eli LillyNov 051965
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vincristine Oncovin Eli LillyJul 101963
vinorelbine Navelbine
Single agent or incombination withcisplatin for the first-linetreatment of ambulatorypatients withunresectable, advancednon-small cell lungcancer (NSCLC).
GlaxoSmithKlineDec 231994
Navelbine is indicated as
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non-small cell lungcancer (NSCLC).
vinorelbine Navelbine
Navelbine is indicated asa single agent or incombination withcisplatin for the first-linetreatment of ambulatorypatients withunreseactable, advancednon-small cell lungcancer (NSCLC). Inpatients with Stage IVNSCLC, Navelbine isindicated as a singleagent or in combinationwith cisplatin. In StageIII NSCLC, Navelbine isindicated in combinationwith cisplatin.
GlaxoSmithKlineNov 052002
vorinostat Zolinza
for the treatment ofcutaneousmanifestations ofcutaneous T-celllymphoma (CTCL) inpatients withprogressive, persistent,or recurrent disease onor following twosystemic therapies.
MerckOct 062006
zoledronate Zometa
the treatment of patientswith multiple myelomaand patients withdocumented bonemetastases from solidtumors, in conjunctionwith standardantineoplastic therapy.Prostate cancer shouldhave progressed aftertreatment with at leastone hormonal therapy
NovartisFeb 222002
zoledronic acid ZometaTreatment ofhypercalcemia ofmalignancy
NovartisAug 202001
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