FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

Regulatory approval: On Oct 14, 2026, the FDA approved an expanded indication for nogapendekin alfa inbakicept-pmln (Anktiva) administered intravesically with BCG for adults with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC). The label now includes patients with high-grade papillary-only tumors, revising the prior indication limited to carcinoma in situ (CIS) with or without papillary tumors. The expansion was based on FDA review and extrapolation from previously demonstrated efficacy in CIS-containing disease.

FDA regulatory approval (Oct 14, 2026)

The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva; Altor BioScience, LLC/ImmunityBio) in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC), expanding the prior indication from CIS (± papillary tumors) to also include high-grade papillary-only tumors.

Evidence base and rationale

Efficacy was previously demonstrated in Cohort A of QUILT-3.032 (NCT03022825), a single-arm multicenter trial (n=77) in BCG-unresponsive, high-risk NMIBC with CIS (± Ta/T1). Patients received intravesical induction with BCG followed by maintenance up to 37 months. The primary outcome was complete response (CR) (cystoscopy, urine cytology, biopsy); duration of response (DoR) was additional.

  • CR rate: 62% (95% CI, 51–73)
  • Among responders: 58% had DoR ≥12 months; 40% had DoR ≥24 months

For the expanded population, FDA stated the decision was based on review of available scientific information and extrapolation from CIS-containing disease due to overlapping clinical/non-clinical features.

Safety and dosing highlights

Common adverse reactions (≥15%) included increased creatinine, dysuria, hematuria, urinary frequency/urgency, UTI, increased potassium, musculoskeletal pain, chills, and pyrexia. The prescribing information includes a warning that delaying cystectomy can lead to metastatic bladder cancer.

Full prescribing information will be posted on Drugs@FDA.

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