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Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU Approval as First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer

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Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU Approval as First HER2 Directed Therapy for HER2 Low Metastatic Breast Cancer

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  • 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

Related Post:- Daiichi Sankyo and AstraZeneca Receive Health Canada’s Approval of Enhertu (trastuzumab deruxtecan) for HER2-Low Metastatic Breast Cancer

Click here to­ read the full press release 

Senior Editor

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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