Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

December 14, 2020 Auto Bot approval, AstraZeneca, cancer, CHMP, Daiichi Sankyo, EU, HER2, Metastatic, Positive, regulatory, trastuzumab 0

Shots:

  • The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine
  • The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with the P-I trial
  • EC will review the CHMP’s positive opinion to grant MAA for the therapy in the EU. Trastuzumab deruxtecan is a HER2 directed ADC

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