On October 14, 2026, the U.S. Food and Drug Administration (FDA) announced an expansion of the approved indication for Anktiva (nogapendekin alfa inbakicept-pmln). This immunotherapy, when administered alongside Bacillus Calmette-Guerin (BCG), is now approved for adults with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC).

This decision builds upon prior scientific evidence that supported earlier approvals of Anktiva. The FDA's expanded indication aims to provide clinicians with an additional, FDA-approved therapeutic option for managing this challenging patient population.

Healthcare professionals treating NMIBC can now consider the use of Anktiva in relevant patients who are unresponsive to BCG therapy. This marks an important advancement in the management of bladder cancer, reflecting ongoing efforts to improve patient outcomes.