FDA批准Enhertu和Petuzumab的高级HER2+乳癌,显示长期的无进展存活。 FDA approves Enhertu plus Pertuzumab for advanced HER2+ breast cancer, showing longer progression-free survival.

林业发展局已核准Enhertu(fam-trastuzumab deruxtecan-nxki)与Pertuzumab相结合,根据DESTINY-Breast09第3阶段试验,作为对患有非剖析性或转移性HER2-阳性乳腺癌的成人的第一线治疗。 The FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) combined with Pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, based on the phase 3 DESTINY-Breast09 trial. 综合结果显示,标准治疗的中位无进展性存活率为40.7个月,而26.9个月为标准治疗,疾病增加或死亡的风险减少了44%。 The combination showed a median progression-free survival of 40.7 months versus 26.9 months for standard therapy, with a 44% reduction in risk of disease progression or death. 经确认的回复率分别为87%和81%。 Confirmed response rates were 87% and 81%, respectively. 总体生存数据尚未成熟。 Overall survival data were not yet mature. 还批准了一项同伴诊断测试。 A companion diagnostic test was also approved. 常见副作用包括疲劳、呕吐和血解毒性。 Common side effects included fatigue, nausea, and hematologic toxicity. 符合资格的患者现在可以获得这种治疗。 The treatment is now available for eligible patients.