FDA approves new bladder cancer therapy

FDA has approved the IL-15 receptor agonist nogapendekin alfa inbakicept-pmln (Anktiva) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Approval was based on results from the phase 2/3 QUILT-3.032 trial involving 77 patients. According to a manufacturer press release, Anktiva is expected to be available in the U.S. by mid-May 2024.