Daiichi Sankyo and AstraZeneca’ Enhertu Receive the US FDA’s Breakthrough Therapy Designation for HER2 Low Metastatic Breast Cancer
Shots:
- The designation was based on the P-III (DESTINY-Breast04) trial evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 540 patients with HER2 low unresectable or metastatic breast cancer prior treated with 1 or 2 prior lines of CT at multiple sites in Asia, EU & North America
- The results showed an improvement in PFS & OS in patients with HR+ or HR- disease. The safety profile was consistent with previous trials with no new safety concerns, ILD rates were consistent with late-line HER2+ breast cancer trials with a lower rate of grade 5 ILD
- Enhertu (6.4mg/kg) was approved in multiple countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma, based on (DESTINY-Gastric01) trial results
Ref: Businesswire | Image: Daiichi Sankyo
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