ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG)

October 14, 2026: ImmunityBio (NASDAQ: IBRX) said the FDA expanded the ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG label to include adult patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors. The revised indication now covers BCG-unresponsive NMIBC broadly, following the prior April 2024 approval in carcinoma in situ (CIS) with or without papillary tumors.

The company said this is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors. The expansion was based on the FDA’s review of available scientific information, including prior QUILT-3.032 Cohort A results in CIS patients: 62% of 77 patients achieved a complete response (95% CI: 51, 73); among responders, 58% maintained response for at least 12 months and 40% for at least 24 months.

Reported safety was described as tolerable, with common treatment-related adverse events related to bladder instillation, including dysuria, pollakiuria, and hematuria, mostly grade 1-2. The prescribing information warns that delaying cystectomy can lead to muscle-invasive or metastatic bladder cancer, which can be lethal.