FDA expands Anktiva approval in bladder cancer

The FDA on Wednesday expanded the approval of ImmunityBio's Anktiva, given with BCG, to adults with BCG-unresponsive non-muscle invasive bladder cancer whose tumours are high-grade papillary only, a group that until now had no approved treatment of its own.

Why it matters: For these patients the standard option after BCG failure has often been removal of the bladder, so an approved bladder-sparing regimen changes the treatment conversation, and the FDA's method, extrapolating from a related subtype, may guide future approvals.

Data as of Wednesday, October 14, 2026, 12:52 ET. FDA approval announcement of October 14, 2026; OncLive report read in full, including the QUILT-3.032 cohort A figures and the approval history.

The Food and Drug Administration on Wednesday approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva, from Altor BioScience, an ImmunityBio subsidiary), used with BCG, for adults with BCG-unresponsive non-muscle invasive bladder cancer. The label previously covered patients whose disease included carcinoma in situ, with or without papillary tumours; it now also covers patients with high-grade papillary-only tumours, making Anktiva the first treatment approved specifically for that group.

Unusually, the expansion rests on evidence borrowed from the related subtype. The supporting trial, cohort A of QUILT-3.032, enrolled carcinoma in situ patients and produced a complete response rate of 62 percent, with 58 percent of responses lasting at least 12 months and 40 percent at least 24 months. The FDA concluded that the clinical and laboratory similarities between the two tumour types justified extrapolating that efficacy to papillary-only disease, and said it is finalising draft guidance on using carcinoma in situ evidence to support approvals of this kind.

FDA expands Anktiva approval in bladder cancer

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