Rhone-Poulenc Rorer has filed a new drug application with the FDAfor approval to market Taxotere for treatment of breast and non-smallcell lung cancer in the U.S.Bob Pearson, Rhone-Poulenc's director of product communications,said the Collegeville, Pa.-based company also has filed for approvals tosell the cancer drug in Canada and Europe. A market application wasfiled in Japan in May.Pearson said the licensing submissions are based on results of 35studies worldwide involving 1,500 patients.Taxotere is a semi-synthetic compound related to taxol, another cancertreatment. Bristol-Myers Squibb, of New York, has the only FDA-approved taxol product on the market and it is working on a semi-synthetic version.Taxotere is the first semi-synthetic taxol-related compound to reachthis stage in the regulatory process.Taxol has been the focus of controversy because its source, the Pacificyew tree, is endangered. Rhone-Polenc's Taxotere is derived from theneedles of the European yew tree, which is not endangered.In applications for the drug's approval, patients targeted are ones withadvanced stages of breast and non-small cell lung cancer. According toRhone-Poulenc, breast cancer strikes 550,000 women worldwide eachyear, killing more than 100,000, and non-small cell lung cancer afflictsabout 650,000 people, killing more than half a million.Among the evidence Rhone-Poulenc is using to support its new drugapplications are results from recent Phase II trials in the U.S.In June, the company reported that when Taxotere was administered topatients with stage IIIB or stage IV non-small cell lung cancer, theresponse rate was between 31 percent and 38 percent, compared with aresponse rate of 10 percent to 20 percent for patients treated withchemotherapy. The tests revealed that advanced lung cancer patientsreceiving Taxotere experienced a median survival of about 47 weeks,compared with fewer than 30 weeks when treated with chemotherapy.U.S. studies involving treatment of breast cancer with Taxotere werereleased in May. The tests involved patients who had not responded toanthracycline, a commonly used breast cancer chemotherapy. Afterbeing treated with Taxotere, the response rate was 55 percent.In the lung and breast cancer studies, a response was indicated whenpatients experienced a 50 percent or greater reduction in measurabletumor size.Pearson said he could not speculate about when any of the regulatorygroups might act on the drug approval applications. He added that 11months is the average waiting time for cancer-related new drugapplications submitted to the FDA. n
-- Charles Craig
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