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EU approves Enhertu for HER2-positive early breast cancer, triggering $75M milestone payment
AZNAstrazeneca PLC
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant therapy. The approval is based on the DESTINY-Breast05 Phase III trial, which demonstrated that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine (T-DM1). As a result of this regulatory milestone, AstraZeneca is due to pay Daiichi Sankyo $75 million. This marks the first approval of Enhertu in the curative-intent early breast cancer setting in the EU.