AstraZeneca, Daiichi Sankyo announce Datroway sBLA granted priority review

Daiichi Sankyo and AstraZeneca’s (AZN) supplemental biologics license application, or sBLA, for Datroway has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is June 2.