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# ImmunityBio Refiles Bladder Cancer BLA
- URL: https://www.fdaweb.com/immunitybio-refiles-bladder-cancer-bla/
- Published: 2023-10-23T12:00:00.000Z
- Updated: 2026-09-14T14:14:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155627

ImmunityBio has resubmitted 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* (CIS) with or without Ta or T1 disease. The original BLA was issued a complete response letter in May that cited deficiencies related to FDA’s pre-license inspection of third-party contract manufacturing organizations, ImmunityBio 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 said at the time that FDA did request “updated duration of response data” and updated safety data.

The BLA is supported by data from the company’s studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), ImmunityBio says. “An update of the duration of response regarding the responders identified by the FDA in the efficacy population for BCG unresponsive subjects with high-risk CIS disease was provided in the BLA resubmission,” it says. “This update demonstrated a prolonged duration of remission in responding subjects, with a median duration of CR \[complete response\] not yet reached with a follow-up in responders exceeding 28 months, and a safety profile as reported previously. The updated duration of CR in these responding BCG-unresponsive subjects showed that the probability of maintaining a CR for greater than or equal to 24 months was 60%, with a cystectomy-free rate at greater than 24 months of over 90%.”

Additionally, ImmunityBio says it provided an update on the long-term follow-up (QUILT-205) of subjects receiving N-803 plus BCG that examines the survival of the nine subjects entering the trial since 2014\. “All nine subjects (100%) achieved a complete remission and the results are published in *Oncoimmunology*,” it says. “Of the nine subjects, two were deceased from causes other than bladder cancer and one was lost to follow-up. Of the six subjects available for follow-up (QUILT-205), six out of six subjects (100%) demonstrated long-term complete remission with bladder preservation over a median survival period of 8.8 years and all six subjects have avoided a cystectomy to date.”

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.