The approval 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 & metastatic breast cancer prior treated with one or two prior lines of CT at multiple sites in Asia, EU & North America
The results showed a 50% reduction in risk of disease progression or death, m-PFS (9.9 vs 5.1mos.); m-OS (23.4mos. vs 16.8mos.) with a 36% reduction in risk of death. The safety profile was consistent with prior clinical trials with no new safety concerns, 12% had confirmed ILD or pneumonitis
The application is being reviewed in multiple countries. Enhertu (6.4mg/kg) was approved in multiple countries for LA or metastatic HER2+ gastric or GEJ adenocarcinoma
Ref: AstraZeneca | Image: AstraZeneca
