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

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

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  • 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

­ Ref: Business wire | Image: GlassDoor

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