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# Priority Review for Alternative Imfinzi Dosing
- URL: https://www.fdaweb.com/priority-review-for-alternative-imfinzi-dosing/
- Published: 2020-08-18T12:00:00.000Z
- Updated: 2026-09-14T16:25:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147457

FDA has granted AstraZeneca a priority review for its supplemental BLA for Imfinzi (durvalumab) and a new four-week, fixed-dose regimen for treating approved indications for non-small cell lung cancer (NSCLC) and bladder cancer. If approved, the drug could be administered intravenously every four weeks at a fixed dose of 1,500mg in unresectable Stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer. This would be an alternative to the currently approved weight-based dosing of 10mg/kg every two weeks. The submission was based on data from several Imfinzi clinical trials, including results from the Phase 3 CASPIAN trial,which used the four-week, fixed-dose regimen during maintenance.