美国食品和药物管理局批准了罗氏公司的ESR1突变高级乳腺癌药物组合,并将在2026年12月18日前进行审查. FDA accepted Roche’s drug combo for ESR1-mutated advanced breast cancer, with review due by Dec. 18, 2026.

美国食品和药物管理局批准了罗氏公司的申请,用于治疗先进乳腺癌患者,这些患者在先前内分泌治疗后出现ESR1突变. The FDA has accepted Roche’s application for giredestrant plus everolimus to treat advanced breast cancer in patients with ESR1 mutations who have progressed after prior endocrine therapy. 这次审查预计于2026年12月18日结束,其依据是第三阶段试验数据,显示疾病增加或总体死亡减少44%,由ESR1组成的分组减少62%。 The review, expected to conclude by December 18, 2026, is based on phase III trial data showing a 44% reduction in disease progression or death overall, and a 62% reduction in the ESR1-mutated subgroup. 如果得到批准,这将是在CDK4/6抑制剂治疗后通过的第一种口服SERD疗法。 If approved, it would be the first oral SERD regimen approved after CDK4/6 inhibitor treatment.