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

January 20, 2021 Auto Bot approval, AstraZeneca, Daiichi Sankyo, Enhertu, EU, regulatory 0

Shots:

  • The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine
  • Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2+ BC prior treated with at least one dose of Enhertu (5.4 mg/kg) in clinical studies
  • Enhertu is a HER2 directed ADC and has received EMA’s CHMP accelerated assessment in Mar’20 for the same indication

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