Shots:
The sBLA was based on the P-III (DESTINY-Breast04) trial evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients with HR+ or HR-, HER2 low unresectable or metastatic breast cancer at multiple sites in Asia, EU & North America. The US FDA’s decision is expected in Q4’22
The therapy sowed superior clinical efficacy in PFS & OS. The safety profile was consistent with prior trials with no new safety concerns. The results were presented at ASCO 2022 & published in NEJM
The application is being reviewed under the US FDA’s RTOR program & Project Orbis for cancer patients shortly. Enhertu (6.4mg/kg) was approved in multiple countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma
Ref: Bussinesswire | Image: Daiichi Sankyo
