FDA Hands AstraZeneca, Daiichi Sankyo’s Breast Cancer Drug Priority Review

The FDA granted AstraZeneca and Daiichi Sankyo’s breast cancer biologic trastuzumab deruxtecan a priority review for HER2-positive metastatic breast cancer.

AZ’s executive vice president of oncology R&D, José Baselga, said the antibody drug conjugate “has the potential to transform the treatment landscape for patients with HER2-positive metastatic breast cancer” that only have limited treatment options available.

The treatment previously received the agency’s breakthrough therapy and fast track designations.