Daiichi Sankyo’ Enhertu (trastuzumab deruxtecan) Receives the MHLW Approval for the Treatment of HER2 Positive Metastatic Breast Cancer
Shots:
- MHLW has approved Enhertu for the treatment of HER2+ unresectable or recurrent breast cancer after prior CT incl. trastuzumab and a taxane
- The approval was based on the P-III (DESTINY-Breast03) trial evaluating the efficacy & safety of Enhertu (5.4mg/kg) vs T-DM1 in 524 patients 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 safety profile was consistent with prior trials with no new safety concerns
- Enhertu (5.4mg/kg) was approved in 35+ countries for unresectable or metastatic HER2+ breast cancer, based on the results from the (DESTINY-Breast03) trial
Ref: Daiichi Sankyo | Image: Daiichi Sankyo
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