Taxol, Bristol-Myers Squibb's anti-cancer drug, has been cleared bythe FDA for use in the treatment of breast cancer when other methodsfail or a relapse occurs. Taxol was approved for treatment of refractoryovarian cancer after failure of first-line or subsequent chemotherapy inDecember 1992."We appreciate the speed with which the FDA addressed oursupplemental application to include the metastatic breast cancerindication," the Princeton, N.J.-based company said. The applicationwas submitted in July 1993 and unanimously approved by the FDA'sOncologic Drugs Advisory Committee.Taxol (paclitaxel) has been hailed as a wonder-drug in the fight againstcancer. However, it became embroiled in controversy withenvironmentalists because it was derived from the bark of theendangered Pacific yew tree. In 1992, Bristol-Myers Squibb(NYSE:BMY) ended its yew-bark harvesting operations and filed anapplication with the FDA for clearance to market Taxol produced bysemi-synthetic methods.Bob Pearson, a spokesman for Rhone-Poulenc Rorer, which plans tofile a new drug application with the FDA in the third quarter for itsrival drug Taxotere (docetaxel), had no comment for BioWorld on thenew approval given Taxol. Taxotere is derived from the needles of theEuropean yew tree, which is not endangered. In Phase II clinical trialsit has shown promising results against a variety of cancers, accordingto findings presented at a recent cancer congress in Amsterdam, theNetherlands.According to Stephen Carter, Bristol-Myers Squibb's senior vicepresident for worldwide clinical research and development, thecontinuing development of Taxol is the largest research program thecompany has ever mounted for a single pharmaceutical and will remainits number one priority."There are a lot of resources going into Taxol," Robert Laverty,Bristol-Myers Squibb's director of public affairs told BioWorld,although he would not be specific about its share of the company'sresearch budget. He said the company continues to investigate newpossibilities for the drug, and is currently in phase II and III clinicaltrials of Taxol as a treatment for non-small cell lung cancer and headand neck cancers.Under the FDA's guidelines for the use of Taxol in breast cancer, thedrug may be administered as an injection concentrate after failure ofcombination chemotherapy for metastatic disease or relapse within sixmonths of adjuvant chemotherapy. Prior therapy should have includedan athracycline unless clinically contraindicated.Laverty said a treatment would be considered to have failed when atumor in a patient treated with chemotherapy subsequently began togrow again, or when chemotherapy or other treatments failed to haltthe cancer.The most common side effects of Taxol are a reduction in white bloodcell count and hair loss. Numbness in the extremities and muscle orbone pain may also occur.As an injection concentrate, it will be administered in diluted form asan intravenous infusion over a period of three hours. The company saysthis will allow it to be administered on an outpatient basis. Under anOncology Access Program the company established in 1973, Taxol willbe provided free of charge to people who are uninsured or lack theability to pay for the treatment. The company also operates aReimbursement Assistance Program to help physicians find insurancecoverage for their patients.

-- Philippa Maister

(c) 1997 American Health Consultants. All rights reserved.