Rhone-Poulenc Rorer Inc. said that its anti-cancer drug, Taxotere,has received its first regulatory approval in Mexico for treatment ofbreast and lung cancers.
The Collegeville, Pa., company, a subsidiary of France-based Rhone-Poulenc Group, said it expects to begin selling the drug by April ofnext year.
Rhone-Poulenc also has filed for approvals of Taxotere, which is asemi-synthetic compound related to taxol, in the U.S., Canada andEurope.
The FDA's Oncologic Drugs Advisory Committee is expected toannounce its recommendation for Taxotere Tuesday, five monthsafter Rhone-Poulenc filed its new drug application for the cancertreatment.
Bristol-Myers Squibb, of New York, has the only FDA-approvedtaxol product on the market. Taxol is derived from the endangered-Pacific yew tree while Taxotere is made from the needles of theEuropean yew tree, which is not endangered.
In Mexico, Taxotere will be administered on an outpatient basis forone hour once every three weeks. Use of corticosteriods prior toinfusion of Taxotere also is recommended.
The Taxotere treatments are targeted for patients with advancedbreast cancer and advanced non-small cell lung cancer, which is themost common form of lung cancer.
Rhone-Poulenc said it has supported its licensing applications withdata from 35 studies worldwide involving 1,500 patients. Thecompany has ongoing Phase II and Phase III trials in Mexico, theU.S., Canada and Europe.
Results from previous Phase II trials showed that the response ratewas between 31 percent and 38 percent for advanced lung cancerpatients treated with Taxotere compared with a response rate ofbetween 10 percent and 20 percent for patients receiving onlychemotherapy. The Taxotere patients also had a median survival rateof 47 weeks compared with 30 weeks for chemotherapy patients.
In data from Phase II studies involving advanced breast cancerpatients who did not respond to anthracycline, the response rate was55 percent when they were treated with Taxotere.
In both the lung and breast cancer studies a response was indicatedwhen patients experienced a 50 percent reduction in measurabletumor size.
Rhone-Poulenc Rorer's stock (NYSE:RPR) closed Wednesday at$39.12, up 50 cents. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.