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Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receive EU Approval for HER2 Positive Metastatic Breast Cancer

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Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receive EU Approval for HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receive EU Approval for HER2 Positive Metastatic Breast Cancer

Shots:

  • 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

Click here to­ read the full press release 

Neha

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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