FDA expands Anktiva approval in BCG-unresponsive NMIBC

On October 14, 2026, FDA expanded the indication for Anktiva (nogapendekin alfa inbakicept-pmln), an interleukin-15 (IL-15) receptor agonist, in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The revised label extends use beyond carcinoma in situ (CIS) with or without papillary tumors to also include patients with high-grade papillary-only disease.

The decision makes Anktiva plus BCG the first FDA-approved therapy specifically indicated for BCG-unresponsive NMIBC with papillary-only tumors. Papillary tumors account for an estimated 85% of NMIBC cases, yet patients with high-grade disease that no longer responds to BCG have had no FDA-approved treatment option and face substantial risks of recurrence and progression.

The expanded approval was based on FDA’s review of available scientific information and previously demonstrated efficacy in patients with BCG-unresponsive NMIBC containing CIS. In Cohort A of the QUILT-3.032 trial, 62% of patients with BCG-unresponsive high-risk NMIBC with CIS, with or without papillary disease, achieved a complete response with Anktiva plus BCG. Among responders, 58% maintained their response for at least 12 months and 40% for at least 24 months, demonstrating durable disease control.

FDA determined that efficacy findings from patients with CIS could reasonably be extrapolated to those with high-grade papillary-only disease because both tumor types are aggressive urothelial carcinomas that frequently coexist, share overlapping clinical characteristics, and carry a high risk of recurrence and progression after BCG failure.

Most treatment-related adverse events were grade 1 to 2 and related to bladder instillation, consistent with the known effects of BCG alone. The most common adverse reactions were increased creatinine, dysuria, hematuria, urinary frequency, urinary urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

“Patients with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options. The availability of an FDA-approved treatment for this population represents an important addition to the treatment landscape, providing appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder,” said Sam S. Chang, MD, professor of urology and chief surgical officer at Vanderbilt Ingram Cancer Center.

Sources: FDA. (2026 Oct 14). FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer; ImmunityBio. (2026 Oct 14). FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease