07:45 AM EDT, 09/24/2025 (MT Newswires) -- Astrazeneca ( AZN ) said Wednesday the US Food and Drug Administration has granted priority review to its and Daiichi Sankyo's supplemental biologics license application for Enhertu combined with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The agency's action date for the regulatory decision is expected in Q1 2026, the company said.

Enhertu, which was recently granted the FDA's breakthrough therapy designation, is a specifically engineered HER2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca ( AZN ) and Daiichi Sankyo, Astrazeneca ( AZN ) said.