The approval was based on the P-III (DESTINY-Breast03) trial evaluating Enhertu (5.4mg/kg) vs T-DM1 in 524 patients with HER2+ unresectable & metastatic breast cancer prior treated with trastuzumab & a taxane at multiple sites in Asia, EU, North America, Oceania & South America
The results showed a 72% reduction in risk of disease progression or death, m-PFS (not reached vs 6.8mos.). The 2EPs showed an improved OS but were not yet mature, patients were alive at 9mos. over 91.3% with T-DM1, ORR (79.7% vs 34.2%), median duration of treatment was 11.3mos., grades 3 & 5 were reported in 0.7% & 1.4% of patients
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: Bussinesswire | Image: Daiichi Sankyo
