Taxotere Clears Major Marketing Hurdle In USA

At its second attempt, Rhone-Poulenc Rorer has been granted a recommendation for approval from the US Food and Drug Administration's Oncologic Drugs Advisory Committee for its new anticancer drug Taxotere (docetaxel). The panel said that the drug should be approved for the treatment of patients with locally advanced or metastatic breast cancer, whose disease has progressed during anthracycline-based therapy or has relapsed during adjuvant anthracycline-based therapy.

The ODAC's recommendation for approval comes 10 months after the panel turned down the New Drug Application for Taxotere, submitted by R-PR in July last year, (Marketletter December 19, 1994). At the time, the panel had asked for more information on the safety of the compound, particularly in the primary health care setting. At the earlier ODAC meeting, R-PR was also seeking approval to market Taxotere for non-small cell lung cancer, but this was not on the agenda of the latest meeting.

Breast cancer is the most common form of cancer in US women, with an estimated 182,000 new diagnoses in 1995. It kills a total of 46,000 women each year. While 95% of women diagnosed with breast cancer in its earliest stages may be alive five years after the initial diagnosis, only 10% of women with the most advanced stage of breast cancer (Stage IV) are alive five years later, because few, if any, therapies work at this stage. It is in this latter group that Taxotere has revealed significant benefit.