09:25 AM EDT, 04/02/2024 (MT Newswires) -- AstraZeneca ( AZN ) and Daiichi Sankyo said Tuesday the US Food and Drug Administration has accepted their Biologics License Application for datopotamab deruxtecan to treat adult patients with unresectable or metastatic hormone receptor breast cancer.

Datopotamab deruxtecan, discovered by Daiichi Sankyo, is being jointly developed by Daiichi Sankyo and AstraZeneca ( AZN ). The BLA indication is intended for patients who have received prior systemic therapy for unresectable or metastatic disease.

The Prescription Drug User Fee Act date, the US Food and Drug Administration action date for its regulatory decision, is set for Jan. 29, 2025, the companies said.

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