林业发展局批准Enhertu和Perjeta作为HER2-呈阳性的乳癌的一线治疗,以提高存活率和反应率。
FDA approves Enhertu plus Perjeta as first-line treatment for advanced HER2-positive breast cancer, improving survival and response rates.
林业发展局已经批准AstraZeneca和Daichi Sankyo的Enhertu,连同Roche的Perjeta,作为先进的HER2-呈阳性的乳腺癌的第一线治疗方法,标志着与以前作为第三线治疗方法使用相比的重大转变。
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu, combined with Roche’s Perjeta, as a first-line treatment for advanced HER2-positive breast cancer, marking a major shift from its prior use as a third-line therapy.
根据对1 157名未经治疗的病人进行的一项试验,该综合疗法将中位无进展的存活率延长到40.7个月,而标准治疗为26.9个月,肿瘤反应率为87%。
Based on a trial of 1,157 untreated patients, the combination extended median progression-free survival to 40.7 months—compared to 26.9 months with standard treatment—and achieved a tumor response rate of 87%.
还批准了两项同伴诊断,以确定符合条件的病人。
Two companion diagnostics were also approved to identify eligible patients.
总体生存数据尚未完成。
Overall survival data were not yet complete.