The FDA has approved ImmunityBio's Anktiva, an IL-15 receptor agonist immunotherapy, for patients with Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC).
In trials, Anktiva, in combination with BCG, induced prolonged and durable responses, with the duration of complete response exceeding 47 months in some cases. The therapy was well-tolerated by patients, exhibiting minimal side effects. These results surpassed the clinical benchmarks previously established by the International Bladder Cancer Group (IBCG) for meaningful treatment outcomes in NMIBC.
NMIBC with CIS is a high-grade, non-invasive form of bladder cancer characterized by flat, high-grade cancer cells on the bladder's inner surface. When CIS does not respond to BCG, the standard therapy for high-risk NMIBC, it is termed 'BCG-unresponsive'. Patients with this condition face a higher risk of disease progression to muscle-invasive stages and often require more aggressive treatment approaches.
Anktiva is scheduled to be available in the U.S. by mid-May 2024.
The approval is ImmunityBio's second effort to gain FDA signoff for Anktiva after the agency initially rejected their application ahead of the drug's PDUFA date in May 2023. The FDA cited deficiencies found during an inspection of the company's CDMOs as well as made recommendations on chemistry, manufacturing and controls issues. ImmunityBio resubmitted its BLA in October 2023.
