美国食品药品监督局批准了新的多发性骨髓瘤治疗组合, FDA approves new multiple myeloma treatment combo that extends survival and avoids hospitalization.

FDA已经批准了Belentamab mafodotin(Blenrep)加上bortezomib和 dexamethasone, 以治疗至少曾接受过两次治疗的复发性或耐药性多重骨髓瘤的成年人。 The FDA has approved belantamab mafodotin (Blenrep) plus bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who’ve had at least two prior treatments. 根据DREAMM-7号试验,这种结合大大改善了无进展生存,比以前的标准降低了51%的死亡风险。 Based on the DREAMM-7 trial, the combination significantly improved progression-free survival and reduced the risk of death by up to 51% compared to prior standards. 它是唯一一个经批准在社区环境中使用的BCMA向治疗,避免住院和像细胞因子释放综合征这样的风险. It is the only BCMA-targeted therapy approved for use in community settings, avoiding hospitalization and risks like cytokine release syndrome. 该药物与眼睛有关的副作用和细胞本科症有关,促使人们不断进行安全研究。 The drug is associated with eye-related side effects and cytopenias, prompting ongoing safety research. 这项批准是在联合王国、欧盟、日本和加拿大作出类似决定之后作出的,GlaxoSmithKline在早期治疗阶段对GlaxoSmithKline作了规划试验。 The approval follows similar decisions in the UK, EU, Japan, and Canada, with GlaxoSmithKline planning trials in earlier treatment stages.