Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU Approval as First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer
- The EC has approved Enhertu (HER2-directed ADC) as monotx. for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who received prior CT in the metastatic setting or developed disease recurrence during or within 6mos. of completing adjuvant CT
- The approval was based on the P-III trial (DESTINY-Breast04) evaluating Enhertu (5.4mg/kg) vs CT in a ratio (2:1) in 557 patients at multiple sites in Asia, EU & North America, showed a 50% reduction in risk of disease progression or death, m-PFS (9.9 vs 5.1mos.), 36% reduction in risk of death with m-OS (23.4 vs 16.8mos.)
- The safety profile was consistent with prior trials with no new safety concerns. Enhertu (6.4mg/kg) was approved in 30+ countries for HER2+ gastric or GEJ adenocarcinoma
Ref: Businesswire | Image: Daiichi
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