...While R-PR Delays Taxotere Discussions With FDA Panel

Rhone-Poulenc Rorer has asked the US Food and Drug Administration to remove Taxotere (docetaxel) from the agenda of the next Oncologic Drugs Advisory Committee meeting on June 8, saying that it is not yet appropriate to discuss the drug since R-PR is still doing analysis on existing safety data.

The ODAC rejected a Taxotere application for two cancer indications last year (Marketletter December 19). The panel said at the time that the decision for breast cancer was based on a paucity of toxicity data in Phase II, and suggested that R-PR should continue with Phase III. The lung cancer verdict was the result of concerns about safety in general clinical settings. R-PR hopes to ask the advice of ODAC at a meeting later on in the year.

Meantime, Taxotere plus cisplatin achieves an overall response rate of 50% in patients with advanced non-small cell lung cancer, according to Phase I/II data presented at the American Society of Clinical Oncology meeting.