FDA expands Anktiva approval to include papillary-only bladder cancer

The Food and Drug Administration approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, a subsidiary of ImmunityBio, Inc.) on October 14, 2026, broadening its use in adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The updated indication extends the drug's approved use beyond patients with carcinoma in situ (CIS) with or without papillary tumors to now include patients with high-grade papillary-only tumors. Anktiva is administered with Bacillus Calmette-Guérin (BCG).

The expanded approval was based on a review of available scientific information rather than a new clinical trial. The FDA determined that prior efficacy data from patients with BCG-unresponsive NMIBC containing CIS could be extrapolated to patients with high-grade papillary-only disease, citing overlapping clinical and non-clinical features between the two tumor types.

The original efficacy data came from Cohort A of the QUILT-3.032 trial, a single-arm, multicenter study of 77 patients. The complete response rate was 62% (95% CI: 51, 73). Among patients who achieved a complete response, 58% maintained it for 12 months or more, and 40% for 24 months or more.

The recommended dose is 400 mcg administered intravesically with BCG once weekly for six weeks as induction therapy, followed by maintenance dosing at defined intervals for up to 37 months.

Common adverse reactions occurring in 15% or more of patients included increased creatinine, dysuria, hematuria, urinary frequency, urinary tract infection, musculoskeletal pain, chills, and fever. The prescribing information includes a warning that delaying cystectomy can lead to metastatic bladder cancer, which can be lethal.

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