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AstraZeneca: CHMP Recommends Enhertu For Approval In The EU

September 21, 2026 — 02:22 am EDT

Written by RTTNews.com for RTTNews

(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. Enhertu was discovered by Daiichi Sankyo and is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

At last close on LSE, AstraZeneca shares were trading at 12,500.00 pence.

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