FDA expands Anktiva+BCG for high-grade papillary-only BCG-unresponsive NMIBC

On 14 October 2026, the US Food and Drug Administration expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG. The FDA called it the first approved treatment specifically for BCG-unresponsive, high-grade papillary-only disease.

Evidence basis (bridged from CIS)

The decision builds on Anktiva’s earlier approval for carcinoma in situ (CIS) with or without papillary tumours. That approval rested on trial NCT03022825 in 77 adults: 62% achieved a complete response (no high-grade cancer on follow-up), and of those, 58% maintained response at least 12 months and 40% at least 24 months. For the papillary-only expansion, the FDA cited clinical and laboratory similarities between CIS and high-grade papillary tumours (often coexist, hard to distinguish microscopically, high risk of return/progression when BCG fails) — a bridging approach rather than a new standalone pivotal trial in papillary-only disease alone.

How it is given and safety notes

Anktiva with BCG is given into the bladder by catheter weekly for six weeks, with further treatment based on response for up to 37 months; stop if cancer persists after a second six-week course, returns or progresses, or side effects are unacceptable. Common effects listed by the FDA include painful/frequent urination, urgency, blood in urine, UTIs, muscle/joint pain, chills, fever, and raised creatinine and potassium. Labelling warns that delaying bladder-removal surgery can allow spread and can be fatal. Approval went to Altor BioScience, LLC.

Limitations

This is a regulatory expansion via evidence bridging, not a new randomised comparison in papillary-only patients alone. Individual benefit/risk depends on tumour details and alternatives (including surgery). This is not personal medical advice; patients should discuss options with their oncology team.