FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma.
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma.
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DOI：
10.1158/1078-0432.ccr-22-0618
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发表时间：
2022-11-01
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2020年8月5日，美国食品药品监督管理局（FDA）加速批准belantamab mafodotin-blmf（BLENREP; GlaxoSmithKline）用于治疗至少接受过4种既往治疗（包括抗CD 38单克隆抗体、蛋白酶体抑制剂和免疫调节剂）的复发性或难治性多发性骨髓瘤成人患者。有效性的实质性证据来自II期多中心DREAMM-2试验。患者每3周一次静脉注射belantamab mafodotin 2.5 mg/kg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队列的总体缓解率为31%，3.4 mg/kg队列为34%。角膜病变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。Belantamab mafodotin的美国处方信息包括眼毒性的黑框警告，Belantamab mafodotin仅可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Belantamab mafodotin 2.5 mg/kg每3周一次静脉注射加速批准的数据和FDA审查过程。该批准可能取决于确证性试验中临床获益的验证和描述。
On August 5, 2020, the Food and Drug Administration 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 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Substantial evidence of effectiveness was obtained from the phase 2, multicenter DREAMM-2 trial. Patients received belantamab mafodotin 2.5 mg/kg 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).