AstraZeneca (AZN) said Friday the US Food and Drug Administration granted priority review to its application for an Imfinzi combination therapy to treat muscle-invasive bladder cancer.

The treatment is intended for patients who cannot or choose not to receive cisplatin-based chemotherapy.

The submission is based on a phase 3 trial, which showed the perioperative therapy delivered event-free and overall survival improvements compared with bladder removal surgery with or without approved secondary treatments, the company said.

AstraZeneca said the FDA is expected to make a regulatory decision in Q4.