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  6. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
  1. Resources for Information | Approved Drugs

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

On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors.

Full prescribing information for Anktiva will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was previously demonstrated in Cohort A of QUILT-3.032 (NCT03022825), a single-arm, multicenter trial of 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection. Patients received nogapendekin alfa inbakicept-pmln induction via intravesical instillation with BCG followed by maintenance therapy for up to 37 months. The main efficacy outcome measure was complete response (CR) as determined by cystoscopy, urine cytology, and biopsy. Duration of response (DoR) was an additional efficacy outcome measure. The CR rate was 62% (95% CI: 51, 73). Fifty-eight percent of patients with CR had a DoR ≥ 12 months and 40% had a DoR ≥ 24 months.

The current approval expands the indication to include patients with BCG-unresponsive high-grade NMIBC with papillary-only tumors based on review of available scientific information. While high-grade papillary and CIS tumors have different architectural growth features, both are considered aggressive urothelial carcinomas, frequently coexist, can be difficult to distinguish pathologically, and, in the BCG-unresponsive setting, are associated with high risk for tumor recurrence and progression. Based on the overlapping clinical and non-clinical features of these two histologic types, the FDA concluded that the prior demonstration of efficacy in patients with BCG-unresponsive NMIBC containing CIS could be extrapolated to patients with BCG-unresponsive high-grade papillary disease.

Therefore, the indication for nogapendekin alfa inbakicept-pmln with BCG was expanded to include patients with BCG-unresponsive NMIBC with papillary-only tumors. FDA is working toward finalizing the Guidance for Industry, 'Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment' to address this approach.

The most common adverse reactions (≥15%), including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.

Recommended Dosage

The recommended nogapendekin alfa inbakicept-pmln dose is 400 mcg administered intravesically with BCG once a week for 6 weeks as induction therapy. A second induction course may be administered if patients have residual CIS and/or high-grade Ta tumors at month 3. For maintenance after induction therapy, the recommended dose is 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13, and 19 (for a total of 15 doses). For patients with no evidence of high-grade disease at month 25 and later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations. Treatment should be discontinued for disease persistence after second induction, disease recurrence or progression, or unacceptable toxicity. The maximum treatment duration is 37 months.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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