FDA expands Anktiva indication for certain bladder cancers
FDA’s October 14 action adds adults with BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer to Anktiva’s indication with BCG.
What the record says
FDA approved an expanded indication for nogapendekin alfa inbakicept-pmln, marketed as Anktiva, in combination with BCG. The change extends the prior indication involving carcinoma in situ to include high-grade papillary-only disease. FDA says the expansion follows its review of available scientific information.
Source details and supporting locations.
Practical next step
Patients and clinicians should consult FDA’s notice and current prescribing information when discussing whether the treatment is appropriate.
Limits and what is not established
This is an approval notice, not individual treatment advice or a guarantee of benefit. FDA highlights a warning that delaying cystectomy can allow metastatic bladder cancer to develop.
Sources checked October 15, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information