expanding opportunities for taxol®

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22 MARKET NEWS Expanding opportunities for Thxol® French authorities have now joined various other countries in approving the use of Bristol-Myers Squibb's novel antineoplastic, Taxol® [paclitaxelj for the treatment of malignant ovarian tumours. Approval was based on response rates of 20-37% overall and of 50% in certain patient subgroups. Taxol®, which is already approved in the US and Canada for refractory advanced ovarian cancer, has now also been recommended for approval for metastatic breast cancer in the US and granted approval for this indication in Canada. A factor which greatly contributed to the US FDA advisory committee's unanimous decision to recom- mend approval of the new indication was the dose- response relationship which was demonstrated. In a trial of patients with metastatic breast cancer who relapsed after previous therapy, progression occurred after a mean of 4.2 months in patients treated with Taxol® 175 mg/m 2 compared with 3 months in patients treated with 135 mg/m 2 There was some discussion over the exact wording of the proposed indication and the dose. The final wording agreed on was 'treatment of patients with metastatic breast cancer who have been previously treated who have relapsed within six months of adjuvant therapy or failed to respond or relapsed after treatment for metastatic disease. This prior therapy should have included an anthracycline'. The recommended dose was 175 mg/m 2 8 Jan 1994INPHARMA e 0156-2703194/0919·000221$01.000 Adlalnternatlonal Limited 1994. All rlghb..... -"eel

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Page 1: Expanding opportunities for Taxol®

22 MARKET NEWS Expanding opportunities for Thxol®

French authorities have now joined various other countries in approving the use of Bristol-Myers Squibb's novel antineoplastic, Taxol® [paclitaxelj for the treatment of malignant ovarian tumours. Approval was based on response rates of 20-37% overall and of 50% in certain patient subgroups.

Taxol®, which is already approved in the US and Canada for refractory advanced ovarian cancer, has now also been recommended for approval for metastatic breast cancer in the US and granted approval for this indication in Canada.

A factor which greatly contributed to the US FDA advisory committee's unanimous decision to recom­mend approval of the new indication was the dose­response relationship which was demonstrated. In a trial of patients with metastatic breast cancer who relapsed after previous therapy, progression occurred after a mean of 4.2 months in patients treated with Taxol® 175 mg/m2 compared with 3 months in patients treated with 135 mg/m2•

There was some discussion over the exact wording of the proposed indication and the dose. The final wording agreed on was 'treatment of patients with metastatic breast cancer who have been previously treated who have relapsed within six months of adjuvant therapy or failed to respond or relapsed after treatment for metastatic disease. This prior therapy should have included an anthracycline'. The recommended dose was 175 mg/m2•

8 Jan 1994INPHARMAe 0156-2703194/0919·000221$01.000 Adlalnternatlonal Limited 1994. All rlghb.....-"eel