Enhertu receives European recommendation for an earlier breast-cancer setting

European advisers recommended Enhertu for postoperative treatment of adults with HER2-positive breast cancer who still have invasive disease after preoperative taxane-based chemotherapy and HER2-directed treatment. The drug is jointly developed by AstraZeneca ($AZN) and Daiichi Sankyo. A European Commission decision is still required before the additional use becomes authorized.

The recommendation draws on the Phase 3 DESTINY-Breast05 trial, in which Enhertu reduced the risk of invasive recurrence or death by 53% relative to T-DM1. The result supports potential expansion into this earlier treatment setting, rather than establishing a new drug from scratch. The announcement is a regulatory milestone based on the trial evidence, not a fresh report of drug revenue or an unconditional approval.

Sources:

• AstraZeneca / Daiichi Sankyo — CHMP recommendation, Business Wire