On August 5, 2020, the FDA granted accelerated approval to belantamab mafodotin-blmf (BLENREP; GlaxoSmithKline) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Substantial evidence of effectiveness was obtained from the phase II, multicenter DREAMM-2 trial. Patients received belantamab mafodotin 2.5 or 3.4 mg/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity. The trial demonstrated an overall response rate of 31% in the 2.5 mg/kg cohort and 34% in the 3.4 mg/kg cohort. Keratopathy was the most frequent adverse event, occurring in 71% and 77% of patients, respectively. Other ocular toxicities included changes in visual acuity, blurred vision, and dry eye. The U.S. prescribing information for belantamab mafodotin includes a boxed warning for ocular toxicity, and belantamab mafodotin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. This article summarizes the data and the FDA review process supporting accelerated approval of belantamab mafodotin 2.5 mg/kg intravenously once every 3 weeks. This approval may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

中文翻译：

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FDA 批准摘要：Belantamab Mafodotin 用于治疗复发或难治性多发性骨髓瘤患者

2020年8月5日，FDA加速批准belantamab mafodotin-blmf（BLENREP；葛兰素史克）用于治疗患有复发性或难治性多发性骨髓瘤的成年患者，这些患者之前至少接受过四种治疗，包括抗CD38单克隆抗体、蛋白酶体抑制剂和免疫调节剂。II 期、多中心 DREAMM-2 试验获得了有效性的实质性证据。患者每3周静脉注射一次belantamab mafodotin 2.5或3.4 mg/kg，直至疾病进展或出现不可接受的毒性。该试验表明，2.5 mg/kg 组的总体缓解率为 31%，3.4 mg/kg 组的总体缓解率为 34%。角膜病是最常见的不良事件，分别发生在 71% 和 77% 的患者中。其他眼部毒性包括视力变化、视力模糊和干眼症。美国 Belantamab mafodotin 的处方信息包括针对眼部毒性的黑框警告，并且 belantamab mafodotin 只能通过风险评估和缓解策略下的限制计划获得。本文总结了支持加速批准 belantamab mafodotin 2.5 mg/kg 每 3 周一次静脉注射的数据和 FDA 审查流程。该批准可能取决于验证性试验中临床益处的验证和描述。本文总结了支持加速批准 belantamab mafodotin 2.5 mg/kg 每 3 周一次静脉注射的数据和 FDA 审查流程。该批准可能取决于验证性试验中临床益处的验证和描述。本文总结了支持加速批准 belantamab mafodotin 2.5 mg/kg 每 3 周一次静脉注射的数据和 FDA 审查流程。该批准可能取决于验证性试验中临床益处的验证和描述。