AstraZeneca: positive opinion from CHMP for Enhertu

(CercleFinance.com) - AstraZeneca announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Enhertu (trastuzumab deruxtecan) in the European Union (EU) as a monotherapy for patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies.


Enhertu is an antibody-drug conjugate (ADC) specifically designed for HER2, which is jointly developed and marketed by AstraZeneca and Daiichi Sankyo.

In particular, the CHMP relied on the results of a phase III study showing that Enhertu reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine in patients with unresectable and/or metastatic HER2-positive breast cancer previously treated with trastuzumab + taxane.

If the European Commission follows the CHMP's advice, AstraZeneca said that patients in Europe would then benefit from this important medicine earlier in the treatment of their disease, improving their chances of achieving better outcomes.


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