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FDA Oncology Drugs Committee Fails to Recommend Taxotere and Ethyol

FDA Oncology Drugs Committee Fails to Recommend Taxotere and Ethyol

ROCKVILLE, Md--To the surprise of many, the FDA Oncology Drugs Advisory Committee recommended that Taxotere (docetaxel, Rhône-Poulenc Rorer) not be approved for marketing at this time. The company was seeking approval of the drug for use in locally advanced or metastatic breast cancer when previous therapy with an anthracycline has failed, and in locally advanced or metastatic non-small-cell lung cancer after failure of platinum-based chemotherapy.

Taxotere was characterized by the committee as being very efficacious , but having serious problems with toxicity. In addition, committee members felt that it was difficult to judge the net benefit of Taxotere based only on phase II trials, and urged that phase III studies be performed.

Ethyol Rejected

Ethyol (amifostine, U.S. Bioscience) also was not recommended for approval. The drug is a cytoprotective agent against acute and cumulative hematologic and renal toxicities associated with alkylating agents such as cyclophosphamide (Cytoxan, Neosar) and platinum agents such as cisplatin (Platinol), and the company was seeking approval for use in ovarian cancer patients receiving those drugs. The committee said that Ethyol produced very little improvement in survival rates and caused significant toxicity (nausea, vomiting, and hypotension).

The committee recommended two drugs for approval: Zinecard (dexrazoxane, Pharmacia) to prevent and/or reduce the incidence and severity of cardiomyopathy associated with use of doxorubicin, and Vesanoid (tretinoin, all-trans-retinoic acid, Hoffman-LaRoche) for the treatment of patients with acute promyelocytic leukemia.

A detailed discussion of the committee's deliberations surrounding these four drugs will appear in next month's issue.

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