Drug approval summaries: Arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene
Drug approval summaries: Arsenic trioxide, tamoxifen citrate, anastrazole, paclitaxel, bexarotene
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DOI：
10.1634/theoncologist.6-1-4
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发表时间：
2001-01-01
期刊：
影响因子：
5.8
通讯作者：
Pazdur, R
中科院分区：
文献类型：
--
作者：
Cohen, MH;Hirschfeld, S;Pazdur, R
本报告总结了美国食品药品监督管理局（FDA）办公室或药物评价1部或肿瘤制剂部最近批准的药物信息。将讨论支持新声明的五种应用：Trisenox（TM）（三氧化二砷）用于在患有急性早幼粒细胞白血病的患者中诱导缓解和巩固，所述患者对类维生素A和蒽环类化疗难治或复发，并且其疾病的特征在于存在t（15;17）易位或PML/RAR-α基因表达;诺伐得（R）（枸橼酸他莫昔芬）用于乳腺手术和放疗后的导管原位癌妇女，以降低浸润性乳腺癌的风险;（阿那曲唑）用于激素受体阳性或激素受体未知的局部晚期或转移性乳腺癌绝经后妇女的一线治疗;紫杉醇（R）（pachaline），175 mg/m2，3 h输注，联合顺铂一线治疗晚期卵巢癌;和Targretin（R）凝胶（贝沙罗汀）用于局部治疗IA和IB期皮肤T细胞癌患者的皮肤病变，不耐受其他治疗或患有难治性或持续性疾病的淋巴瘤患者。提供的信息包括药物治疗的理由开发、研究设计、有效性和安全性结果以及相关参考文献。
This report summarizes information on drugs recently approved by the Food and Drug Administration, Office or Drug Evaluation 1, Division or Oncology Drug Products. Five applications supporting new claims will be discussed: Trisenox(TM) (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(R) (tamoxifen citrate) in women with ductal carcinoma in situ, following breast surgery and radiation, to reduce the risk of invasive breast cancer; Arimidex(R) (anastrazole) for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer; Taxol(R) (pachtaxel), 175 mg/m(2) by 3 h infusion in combination with cisplatin for first-line treatment of advanced ovarian cancer; and Targretin(R) 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.