FDA Oncology Drugs Committee Fails to Recommend Taxotere and Ethyol

January 1, 1995

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.

ROCKVILLE, Md--To the surprise of many, the FDA Oncology DrugsAdvisory Committee recommended that Taxotere (docetaxel, Rhône-PoulencRorer) not be approved for marketing at this time. The companywas seeking approval of the drug for use in locally advanced ormetastatic breast cancer when previous therapy with an anthracyclinehas failed, and in locally advanced or metastatic non-small-celllung 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, committeemembers felt that it was difficult to judge the net benefit ofTaxotere based only on phase II trials, and urged that phase IIIstudies be performed.

Ethyol Rejected

Ethyol (amifostine, U.S. Bioscience) also was not recommendedfor approval. The drug is a cytoprotective agent against acuteand cumulative hematologic and renal toxicities associated withalkylating agents such as cyclophosphamide (Cytoxan, Neosar) andplatinum agents such as cisplatin (Platinol), and the companywas seeking approval for use in ovarian cancer patients receivingthose drugs. The committee said that Ethyol produced very littleimprovement 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 severityof cardiomyopathy associated with use of doxorubicin, and Vesanoid(tretinoin, all-trans-retinoic acid, Hoffman-LaRoche) for thetreatment of patients with acute promyelocytic leukemia.

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