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# FDA Accepts ImmunityBio BLA
- URL: https://www.fdaweb.com/fda-accepts-immunitybio-bla/
- Published: 2022-07-28T12:00:00.000Z
- Updated: 2026-09-14T17:53:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152398

FDA has accepted for review a BLA from ImmunityBio for its N-803 antibody cytokine fusion protein to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMBIC) carcinoma in situ with or without Ta or T1 disease. The company [says](https://us.acrofan.com/detail.php?number=700566&ref=fdaweb.com) the submission is based on positive QUILT 3.032 trial results in which 71% of Bacillus Calmette-Guérin (BCG)-unresponsive NMBIC patients who had failed on previous therapies showed a complete response with a median duration of 26.6 months, cystectomy avoidance rate of 91%, and 100% bladder cancer overall survival at 24 months, with zero serious adverse events.

FDA has granted N-803 breakthrough therapy and fast track designations and set 5/23/23 as the target PDUFA action date.