FDA accepts Enhertu for Priority Review in HER2-positive metastatic breast cancer

The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.

The application has also been granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the second quarter of 2022.

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca (LSE: AZN) and Daiichi Sankyo (TYO: 4568). The UK pharma major’s shares were up 1.3% at 8,657 pence by late morning, while Daiichi gained 3.2% to 2,680 yen in early Tokyo trading.