ImmunityBio, Inc. announced on October 14, 2026, that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG). The expanded approval now includes patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) who have papillary-only tumors.
This marks the first FDA approval to cover BCG-unresponsive NMIBC with papillary-only tumors. Previously, the approval covered patients with carcinoma in situ (CIS) with or without papillary tumors. The company notes that papillary disease represents approximately 85% of the NMIBC patient population.
The expanded label builds on the FDA’s April 2024 approval of ANKTIVA plus BCG. The company cites efficacy data from the QUILT-3.032 trial, Cohort A, where 62% of 77 patients achieved a complete response. Among those responders, 58% maintained a response for at least 12 months and 40% for at least 24 months.
The safety profile of ANKTIVA plus BCG is described as tolerable, with the most common treatment-related adverse events being bladder instillation-related issues such as dysuria, pollakiuria, and hematuria. The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer.
