Atanas Atanasov, Professor at Danube Private University Austria, shared on X:
“Anktiva + BCG approval expands.
Now for adults with BCG-unresponsive, high-grade papillary-only bladder cancer that has not invaded muscle.
FDA drew on evidence from a related subtype.”
Read the full announcement:
More information about the FDA approval:
- On October 14, 2026, the FDA approved Anktiva (nogapendekin alfa inbakicept-pmln) plus BCG for adults with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer (NMIBC), the first approved treatment for this population.
- Basis for approval: The decision relied on evidence from Anktiva’s previous approval for bladder cancer carcinoma in situ, supported by clinical and laboratory evidence.
- Administration: The treatment is delivered directly into the bladder with BCG once weekly for six weeks, with further treatment depending on response and potentially continuing for up to 37 months.
- Safety: Common side effects include urinary symptoms, blood in the urine, infections, fever, chills, and muscle or joint pain. Delaying necessary bladder-removal surgery may allow the cancer to progress.
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