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# Complete Response on Bladder Cancer BLA
- URL: https://www.fdaweb.com/complete-response-on-bladder-cancer-bla/
- Published: 2023-05-11T12:00:00.000Z
- Updated: 2026-09-14T18:31:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154428

FDA has issued ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma *in situ* with or without Ta or T1 disease. The letter cites deficiencies related to FDA’s pre-license inspection of third-party contract manufacturing organizations, ImmunityBio says. “Satisfactory resolution of the observations noted at the pre-license inspection is required before the BLA may be approved,” it says.

The agency also provided recommendations specific to additional chemistry, manufacturing and controls issues and assays that need to be resolved, it adds. While no new preclinical studies or Phase 3 clinical trials were requested, the company says FDA did request “updated duration of response data” and updated safety data. ImmunityBio plans to request a meeting with FDA as soon as possible to address the letter’s contents.

Anktiva is described as an interleukin-15 superagonist fusion protein that is designed to induce expansion of native NK and CD8+ T-cells without concurrent stimulation of T-regulatory cells. The BLA was based on data from the QUILT 3.032 trial. The trial demonstrated that 71% of BCG-unresponsive NMIBC patients who had failed on previous therapies had a complete response with a median duration of 26.6 months, the company says. It also showed a cystectomy avoidance rate of 91%, and 100% bladder cancer overall survival at 24 months.