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FDA批准daratumumab联合标准治疗用于多发性骨髓瘤

FDA approves daratumumab in combination with standard therapy for multiple myeloma

发布者:Frontline Medical News 发布时间:2016-12-7

The Food and Drug Administration has approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

FDA已批准daratumumab联合来那度胺与地塞米松或硼替佐米与地塞米松,用于治疗之前曾接受至少一种药物治疗的多发性骨髓瘤患者。

The drug was approved last year as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.

去年,该药物已获准作为单药治疗用于曾接受至少三种药物(包括蛋白酶体抑制剂和免疫调节剂)治疗的多发性骨髓瘤患者,或是对蛋白酶体抑制剂和免疫调节剂治疗效果不佳的患者。

The current approval of daratumumab (Darzalex) in combination with standard therapy is based on improvement in progression-free survival (PFS) in two phase III trials, the FDA said in a written statement.

FDA在一份书面声明中指出,此次批准daratumumab(Darzalex)与标准治疗联合用药,是基于在两项III期试验中无进展生存期(PFS)均获得改善。

In the POLLUX trial, median PFS had not been reached in the daratumumab plus lenalidomide and dexamethasone arm and was 18.4 months among patients getting lenalidomide and dexamethasone alone (HR=0.37; 95% CI: 0.27, 0.52; P less than.0001).

在POLLUX试验中,daratumumab联合来那度胺与地塞米松治疗组尚未到达中位PFS,而单纯接受来那度胺与地塞米松治疗患者中位PFS为18.4个月(HR,0.37;95% CI,0.27~0.52;P<0.0001)。

In the CASTOR trial, which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone, the estimated median PFS had not been reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio, 0.39; 95% confidence interval, 0.28-0.53; P less than .0001).

在CASTOR试验中,比较了daratumumab联合硼替佐米和地塞米松与硼替佐米和地塞米松的疗效,daratumumab治疗组尚未到达预期中位PFS,而对照组为7.2个月(HR,0.39;95% CI,0.28~0.53;P<0.0001)。

The most frequently reported adverse reactions in POLLUX were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions in CASTOR were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea.

在POLLUX试验中报告最为频繁的不良反应包括输液反应、腹泻、恶心、疲乏、发热、上呼吸道感染、肌肉痉挛、咳嗽以及呼吸困难。在CASTOR试验中报告最多的不良反应为输液反应、腹泻、外周性水肿、上呼吸道感染、外周感觉神经病变、咳嗽以及呼吸困难。

The recommended dose of daratumumab is 16 mg/kg IV (calculated on actual body weight), the FDA said.

FDA指出,daratumumab推荐剂量为16 mg/kg(按实际体重计算),静注给药。

Full prescribing information is available here.

点击链接接可获取处方信息全文。

这两项试验的最新结果已于近期召开的美国血液病学会(ASH)年会上报告。

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来源: Frontline Medical News

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