Daiichi Sankyo, AstraZeneca Enhertu sBLA accepted and granted priority review

Daiichi Sankyo and AstraZeneca’s supplemental biologics license application, or sBLA, for Enhertu has been accepted and granted priority review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The FDA grants priority review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is February 1, 2025. The priority review follows receipt of Breakthrough Therapy Designation granted by the FDA for Enhertu based on data from the DESTINY-Breast06 phase 3 trial in August 2024.