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 (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.