approved immune checkpoint inhibitors

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Page 1: Approved Immune Checkpoint Inhibitors

U.S. FDA Approved Immune-Checkpoint InhibitorsName Target Indications Details

Ipilimumab (Yervoy®)

CTLA-4 • Inoperable or Metastatic Melanoma • Single agent or in combination with Opdivo® (see Opdivo® USPI)• Stage IIIa Melanoma Adjuvantly • At least 1 metastasis >1 mm, no in-transit metastasis

• Undergone complete resection, including total lymphadenectomyNivolumab (Opdivo®)

PD-1 • Inoperable or Metastatic Melanoma • Single agent or in combination with Yervoy®• Metastatic Non-Small Cell Lung Cancer • Failure on platinum-doublet chemotherapy

• Failure on targeted agent (if applicable)• Advanced Renal Cell Carcinoma • Must have received prior treatment with anti-VEGF(R) treatment• Classical Hodgkin Lymphoma • Prior auto-HSCT and brentuximab vendotin• Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma • Disease progression on or after platinum-chemotherapy• Locally Advanced or Metastatic Urothelial Carcinoma • Failure on prior platinum-based chemotherapy

• PD<12months after (neo)adjuvant platinum chemotherapyPembrolizumab

(Keytruda®)PD-1 • Inoperable or Metastatic Melanoma • Single agent

• Metastatic Non-Small Cell Lung Cancer with PD-L1 expression (Tumour Proportion Score ≧1%)

• Failure on platinum-doublet chemotherapy • Failure on targeted agent (if applicable)

• Metastatic Non-Small Cell Lung Cancer with high PD-L1 expression (Tumour Proportion Score ≧50%)

• No prior systemic treatments• No known tumour-driver mutations

• Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma • Disease progression on or after platinum-chemotherapy• Adult and pediatric patients with refractory classical Hodgkin Lymphoma • Disease relapse after 3 prior treatments

Atezolizumab (Tecentriq®)

PD-L1 • Locally Advanced or Metastatic Urothelial Carcinoma • Failure on prior platinum-based chemotherapy• PD<12months after (neo)adjuvant platinum chemotherapy

• Metastatic Non-Small Cell Lung Cancer • Failure on platinum-doublet chemotherapy • Failure on targeted agent (if applicable)

UpToDate as of 15-Mar-2017 - medi-paper.com1 Prescribing information ipilimumab (Yervoy®), revised: 03/20172 Prescribing information pembrolizumab (Keytruda®), revised: 03/20173 Prescribing information nivolumab (Opdivo®), revised: 02/20174 Prescribing information atezolizumab (Tecentriq®), Revised: 10/2016