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Daiichi Sankyo’ Enhertu (trastuzumab deruxtecan) Receives the MHLW Approval for the Treatment of HER2 Positive Metastatic Breast Cancer

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Daiichi Sankyo’ Enhertu (trastuzumab deruxtecan) Receives the MHLW Approval for the Treatment of HER2 Positive Metastatic Breast Cancer

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  • 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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