FDA expands Anktiva approval to papillary-only BCG-unresponsive bladder cancer

What's happened? The US Food and Drug Administration (FDA) has expanded the approved use of ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln), an immunotherapy given alongside the standard bladder cancer treatment BCG, to adults with high-grade papillary-only non-muscle-invasive bladder cancer (NMIBC) that has not responded to BCG. The decision was announced on 14 October 2026.

Why it matters: NMIBC is a bladder cancer that has not yet grown into the deep muscle layer of the bladder wall. Until now, Anktiva plus BCG was only approved for patients whose tumours included a component called carcinoma in situ (CIS) — flat, higher-risk surface lesions. The expansion means patients with papillary-only tumours (growths that protrude into the bladder cavity) now also have an approved bladder-sparing option instead of surgery to remove the bladder.

The evidence: The approval is based on cohort A of the single-arm QUILT-3.032 trial, in which 77 patients received Anktiva plus BCG. 62% achieved a complete response (no detectable cancer); among responders, the response lasted at least 12 months in 58% and at least 24 months in 40%. The FDA extrapolated efficacy from the earlier CIS approval, noting the overlapping clinical and biological features of the two disease forms.

Read more: FDA, 14 October 2026 · OncLive, 14 October 2026