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# ImmunityBio BLA for Bladder Cancer Therapy
- URL: https://www.fdaweb.com/immunitybio-bla-for-bladder-cancer-therapy/
- Published: 2022-05-23T12:00:00.000Z
- Updated: 2026-09-14T17:45:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151869

ImmunityBio has submitted a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The submission is based on data from the company’s pivotal QUILT 3032 study (NCT03022825), where 71% of patients who had failed on previous therapies showed an over 50% increase in both response and median duration compared to the FDA-approved alternatives valrubicin and pembrolizumab.  
  
The company says the treatment can be delivered directly to the bladder (intravesically) to induce natural killer cells and T cells, thus “providing a new treatment option for patients with this form of bladder cancer.” It says the therapy, if approved, would give patients a greater chance to avoid removal of the bladder itself (radical cystectomy).  
  
N-803 is believed to work by stimulating CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation, ImmunityBio says.