FDA Expands Anktiva Plus BCG to Papillary-Only BCG-Unresponsive NMIBC

The FDA has expanded the approved indication for nogapendekin alfa inbakicept-pmln (Anktiva, ImmunityBio) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors, ImmunityBio announced.

The updated label lists the interleukin-15 (IL-15) receptor agonist, in combination with BCG, for adult patients with BCG-unresponsive NMIBC. This builds on the FDA’s April 2024 approval of the combination for BCG-unresponsive NMIBC with 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. It also said papillary disease makes up about 85% of the NMIBC patient population.

According to ImmunityBio, the expanded approval rests on the FDA’s review of available scientific information. That includes the combination’s previously demonstrated efficacy in patients with CIS, with or without papillary tumors. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response (95% CI, 51-73). Among responders, 58% maintained a response for at least 12 months and 40% for at least 24 months. The release did not report efficacy results for patients with papillary-only disease.

The company said the most common treatment-related adverse events were related to bladder instillation, including dysuria, pollakiuria, and hematuria, and that most were grade 1 to 2. The prescribing information warns that delaying cystectomy can lead to muscle-invasive or metastatic bladder cancer, which can be lethal. It advises reconsidering cystectomy if patients have evidence of high-grade disease after a second induction course. Nogapendekin alfa inbakicept is for intravesical use only and may cause fetal harm.

Sam S. Chang, MD, professor of urology and chief surgical officer of the Vanderbilt Ingram Cancer Center, commented in the release. He said patients with high-grade papillary disease that no longer responds to BCG “historically have had limited nonsurgical treatment options.” He added that the approval gives “appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder.”

Source: ImmunityBio. FDA expands Anktiva approval for BCG-unresponsive non-muscle-invasive bladder cancer to cover both papillary and CIS disease. Press release. ImmunityBio; October 14, 2026. Accessed October 14, 2026.