FDA Approves Anktiva for BCG-Unresponsive, Non-Muscle Invasive Bladder Cancer
By Lori Solomon HealthDay Reporter
FRIDAY, April 26, 2024 -- The U.S. Food and Drug Administration has approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
Anktiva is a first-in-class interleukin-15 agonist immunotherapy for NMIBC. The breakthrough therapy designation and approval of Anktiva in combination with BCG is for maintenance therapy for up to 37 months. Anktiva is expected to be available in the United States by mid-May, according to the manufacturer, ImmunityBio.
The approval was based on a trial of 77 patients. The complete response rate was 62 percent, with the upper end of the confidence interval reaching 73 percent. As of the November 2023 cutoff, the duration of complete response was more than 47 months. Side effects ranged from 0 to 3 percent for grade 3/4 adverse events.
"The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses," Patrick Soon-Shiong, M.D., global chief scientific and medical officer at ImmunityBio, said in a statement. "The 'triangle offense' of tumor cell killing by the body's immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin."
Approval of Anktiva was granted to ImmunityBio.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted April 2024
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