July 22, 2025
In a significant advancement for bladder cancer therapy, the FDA granted approval in April 2024 to ImmunityBio’s novel immunotherapy, Anktiva, which combines the interleukin-15 (IL-15) superagonist N-803 with the widely-used Bacillus Calmette-Guerin (BCG) vaccine. Anktiva was specifically approved for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), addressing a critical gap in therapeutic options for these challenging cases. Clinical trial data submitted for regulatory review showed exceptional results, including a 71% complete response rate, which indicates the proportion of patients experiencing complete elimination of detectable cancer cells. Furthermore, the median duration of these responses exceeded two years, suggesting durable clinical benefit and substantial disease control over extended periods. This approval marks a pioneering step in utilizing cytokine-based immunotherapy, specifically enhancing natural killer (NK) cell activity to combat bladder cancer cells. As a result, Anktiva offers a powerful new option for patients who previously had limited treatments available, potentially reducing the frequency of invasive procedures, improving overall survival rates, and significantly enhancing patient quality of life.
Citation: Reuters, April 2024. Available at: https://www.reuters.com
Implication: Anktiva provides a vital immunotherapy option, significantly impacting treatment strategies.