AstraZeneca: CHMP Recommends Enhertu For Approval In The EU

(RTTNews) - AstraZeneca (AZN, AZN.L, ZEG.DE, AZN.ST) and Daiichi Sankyo's (4568.T) Enhertu has been recommended for approval in the European Union by CHMP as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on results from the DESTINY-Breast05 Phase III trial. Enhertu is approved in the US and other countries for the adjuvant treatment of patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment based on DESTINY-Breast05.