> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Priority Review for Bladder Cancer BLA
- URL: https://www.fdaweb.com/fda-priority-review-for-bladder-cancer-bla/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:08:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138087

FDA has accepted for priority review an EMD Serono and Pfizer BLA for avelumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy. The agency has set a user fee review target action date of 8/27.

  
Avelumab is an investigational, fully human anti-PD-L1 antibody. The submission is based on data from JAVELIN, an international clinical development program for avelumab that involves at least 30 clinical programs, including nine Phase 3 trials, and more than 4,000 patients evaluated across more than 15 tumor types.