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The Oncologist, Vol. 6, No. 1, 4-11, February 2001
© 2001 AlphaMed Press

FDA COMMENTARY

Drug Approval Summaries: Arsenic Trioxide, Tamoxifen Citrate, Anastrazole, Paclitaxel, Bexarotene

Martin H. Cohen, Steven Hirschfeld, Susan Flamm Honig, Amna Ibrahim, John R. Johnson, James J. O'Leary, Robert M. White, Grant A. Williams, Richard Pazdur

Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, USA

Correspondence: Martin H. Cohen, M.D., Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, WOC-II, 1451 Rockville Pike, Rockville, Maryland 20852, USA. Telephone 301-594-2473; Fax: 301-594-0498; e-mail: cohenm{at}cder.fda.gov

This report summarizes information on drugs recently approved by the Food and Drug Administration, Office of Drug Evaluation I, Division of Oncology Drug Products. Five applications supporting new claims will be discussed: TrisenoxTM (arsenic trioxide) for induction of remission and consolidation in patients with acute promyelocytic leukemia who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose disease is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression; Nolvadex® (tamoxifen citrate) in women with ductal carcinoma in situ, following breast surgery and radiation, to reduce the risk of invasive breast cancer; Arimidex® (anastrazole) for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer; Taxol® (paclitaxel), 175 mg/m2 by 3 h infusion in combination with cisplatin for first-line treatment of advanced ovarian cancer; and Targretin® gel (bexarotene) for the topical treatment of cutaneous lesions in patients with stage IA and IB cutaneous T-cell lymphoma who have not tolerated other therapies or who have refractory or persistent disease.

Information provided includes rationale for drug development, study design, efficacy and safety results, and pertinent literature references.

Key Words. Arsenic trioxide • Tamoxifen citrate • Anastrazole • Paclitaxel • Bexarotene




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