AstraZeneca gets Q2 2020 PDUFA date for breast cancer ADC

The FDA is set to decide whether to approve AstraZeneca’s HER2-targeting antibody-drug conjugate (ADC) in the second quarter of next year. AstraZeneca landed the PDUFA date for [fam-] trastuzumab deruxtecan after the FDA accepted its approval submission for priority review.