FDA Advisory Meeting on Targretin:
fda.gov
Oncologic Drugs Advisory Committee Meeting.
Date and Time: December 13, 1999, 9 a.m. and December 14, 1999, 8 a.m.
Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
Contact: Karen M. Templeton-Somers, Center for Drug Evaluation
and Research (HFD-21), 301-827-7001.
On December 13, 1999, the committee will discuss: (1) New drug application (NDA) 21-055, Targretin (bexarotene) Capsules, 75 milligrams, Ligand Pharmaceuticals, Inc., indicated for the treatment of patients with all clinical stages (IA-IVB) of cutaneous T-cell lymphoma (CTCL) in the following categories:
Patients with early stage CTCL who have not tolerated other therapies, patients with refractory or persistent early stage CTCL, and patients with refractory advanced stage CTCL; and (2) NDA 20-449/S-011, Taxotere (docetaxel) for Injection Concentrate, Rhone-Poulenc Rorer Pharmaceuticals, Inc., indicated for the treatment of patients with locally advanced or metastatic Non-small Cell Lung Cancer after failure of prior chemotherapy.
On December 14, 1999, the committee will discuss: (1) The design and analysis of active control clinical trials; and (2) NDA 21-156, CelebrexTM (celecoxib), G. D. Searle & Co., indicated for the regression and prevention of adenomatous polyps, which may lead to the development of colorectal cancer in patients with familial adenomatous polyposis. |
