FDA Expands Anktiva to Papillary-Only BCG-Unresponsive Bladder Cancer — First Approval Covering That Population, by Extrapolation from the CIS Cohort
October 14, 2026. FDA approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience/ImmunityBio) with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), revising the prior carcinoma-in-situ (CIS)±papillary indication "to include patients with high-grade papillary-only tumors." Per ImmunityBio, it is "the first FDA-approved therapy for both CIS and papillary-only disease in BCG-unresponsive NMIBC."
The methodologically notable part: no new trial — FDA extrapolated efficacy from Cohort A of QUILT-3.032 (NCT03022825, 77 patients with CIS±Ta/T1 disease), where the complete-response rate was 62% (95% CI: 51, 73), 58% of CRs lasted ≥12 months and 40% ≥24 months. FDA reasoned that while papillary and CIS tumors "have different architectural growth features," both "are considered aggressive urothelial carcinomas, frequently coexist, can be difficult to pathologically distinguish, and, in the BCG-unresponsive setting, are associated with high risk for tumor recurrence and progression" — so the CIS demonstration "could be extrapolated to patients with BCG-unresponsive high-grade papillary disease." FDA is finalizing a guidance to codify this approach.
Label includes the standard warning that delaying cystectomy can lead to metastatic, lethal bladder cancer. Fierce Pharma framed the clearance as coming "after regulatory whiplash" — the sBLA had a January 6, 2027 PDUFA date, so the approval landed early.