RE: arimidex
Es handelt sich um einen neueren nichtsteroidalen Aromatasehemmer (Progesteronhemmer), auch als Anastrozol bekannt. Es ist älteren Präparaten überlegen und wird zur Hormontherapie beim (metastasierenden) Mammakarzinom eingesetzt.
Drug approval summaries: arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene.
AU: Cohen,-M-H; Hirschfeld,-S; Flamm-Honig,-S; Ibrahim,-A; Johnson,-J-R; O'Leary,-J-J; White,-R-M; Williams,-G-A; Pazdur,-R
AD: Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20852, USA.
[email protected]
SO: Oncologist. 2001; 6(1): 4-11
AB: This report summarizes information on drugs recently approved by the Food and Drug Ad-ministration, 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 (tamo-xifen 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 post-menopausal women with hormone receptor positive or hormone receptor unknown locally ad-vanced or metastatic breast cancer; Taxol (paclitaxel), 175 mg/m(2) by 3 h infusion in combina-tion with cisplatin for first-line treatment of advanced ovarian cancer; and Targretin gel (bexaro-tene) 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 di-sease. Information provided includes rationale for drug development, study design, efficacy and safety results, and pertinent literature references.
