FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

The FDA expanded the label for nogapendekin alfa inbakicept-pmln (ANKTIVA, ImmunityBio) on 2026-10-14 to cover BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer, previously limited to CIS with or without papillary disease. The approval rests on extrapolated evidence from cohort A of the QUILT-3.032 trial and is the first approved therapy for papillary-only NMIBC. Papillary tumours account for roughly 85 to 90 percent of NMIBC cases.