FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation
FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation
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DOI：
10.1158/1078-0432.ccr-14-0776
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发表时间：
2014-10-01
影响因子：
11.5
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
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作者：
Kim, Geoffrey;Mckee, Amy E.;Pazdur, Richard
2011年8月17日，美国国防部宣布，S.美国食品药品监督管理局（FDA）批准的维罗非尼片剂（Zelboraf，Hoffmann-LaRoche Inc.）用于治疗具有BRAF（V600 E）突变的不可切除或转移性黑色素瘤患者，如通过FDA批准的测试检测到的。cobas 4800 BRAF V600突变试验（Roche Molecular Systems，Inc.）同时获得批准。一项国际、多中心、随机、开放标签试验，在675例既往未经治疗的BRAF（V600 E）突变阳性的不可切除或转移性黑色素瘤患者中进行，337例患者接受维罗非尼960 mg口服，每日2次，338例患者接受达卡巴嗪1,000 mg/m2静脉注射，每3周一次。接受维罗非尼治疗的患者的总生存率显著提高[HR，0.44; 95%可信区间（CI），0.33-0.59; P
On August 17, 2011, the U. S. Food and Drug Administration (FDA) approved vemurafenib tablets (Zelboraf, Hoffmann-LaRoche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAF(V600E) mutation as detected by an FDA-approved test. The cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.) was approved concurrently. An international, multicenter, randomized, open-label trial in 675 previously untreated patients with BRAF(V600E) mutation-positive unresectable or metastatic melanoma allocated 337 patients to receive vemurafenib, 960 mg orally twice daily, and 338 patients to receive dacarbazine, 1,000 mg/m(2) intravenously every 3 weeks. Overall survival was significantly improved in patients receiving vemurafenib [HR, 0.44; 95% confidence interval (CI), 0.33-0.59; P