AstraZeneca PLCFDA granted Priority Review to AstraZeneca's IMFINZI/enfortumab vedotin application for muscle-invasive bladder cancer, a regulatory milestone that could expand the label.

AstraZeneca said the FDA has granted Priority Review to a supplemental Biologics License Application for IMFINZI with enfortumab vedotin in muscle-invasive bladder cancer. The application targets patients who are ineligible for or decline cisplatin-based chemotherapy, a group with limited treatment choices. Priority Review shortens the FDA review timeline for this regimen, reflecting the agency's view that it may offer a meaningful clinical advance. AstraZeneca, a £192.8 billion pharmaceuticals group focused on prescription medicines, has been building its oncology presence across several tumour types, so any potential label expansion for IMFINZI touches a core therapy area rather than a side project for the business.
AstraZeneca PLCFDA granted Priority Review to AstraZeneca's IMFINZI/enfortumab vedotin application for muscle-invasive bladder cancer, a regulatory milestone that could expand the label.