title: Drug approval summaries: arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene.
abstract: 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: Trisenox (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/m(2) 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.
authors.affiliation: Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA. cohenm@cder.fda.gov
authors.forename: M H
authors.initials: MH
authors.lastname: Cohen
authors.forename: S
authors.initials: S
authors.lastname: Hirschfeld
authors.forename: S
authors.initials: S
authors.lastname: Flamm Honig
authors.forename: A
authors.initials: A
authors.lastname: Ibrahim
authors.forename: J R
authors.initials: JR
authors.lastname: Johnson
authors.forename: J J
authors.initials: JJ
authors.lastname: O'Leary
authors.forename: R M
authors.initials: RM
authors.lastname: White
authors.forename: G A
authors.initials: GA
authors.lastname: Williams
authors.forename: R
authors.initials: R
authors.lastname: Pazdur
mesh_terms: D000077384:Anastrozole; D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000627:therapeutic use*; D000077610:Bexarotene; D001943:Breast Neoplasms / Q000188:drug therapy; D017277:Drug Approval; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy; D009570:Nitriles / Q000627:therapeutic use*; D010087:Oxides / Q000627:therapeutic use*; D017239:Paclitaxel / Q000627:therapeutic use*; D013629:Tamoxifen / Q000627:therapeutic use*; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D014230:Triazoles / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016588:Anticarcinogenic Agents; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D000972:Antineoplastic Agents, Phytogenic; D001152:Arsenicals; D009570:Nitriles; D010087:Oxides; D013764:Tetrahydronaphthalenes; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole; D000077610:Bexarotene; D017239:Paclitaxel; D000077237:Arsenic Trioxide