FDA expands Anktiva indication to high-grade papillary bladder cancer
On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors. The agency extrapolated from earlier data in patients with carcinoma in situ.
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On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The FDA notice says the approval revises the prior indication, which covered carcinoma in situ (CIS) with or without papillary tumors, to include patients with high-grade papillary-only tumors. The FDA lists the sponsor as Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
What the FDA says it relied on
The FDA notice says the efficacy was previously demonstrated in Cohort A of QUILT-3.032 (NCT03022825). It describes that trial as single-arm and multicenter, with 77 patients who had BCG-unresponsive, high-risk NMIBC with CIS, with or without Ta/T1 papillary disease, after transurethral resection.
Patients received nogapendekin alfa inbakicept-pmln by instillation into the bladder with BCG as induction, followed by maintenance therapy for up to 37 months. The main efficacy measure was complete response, as determined by cystoscopy, urine cytology and biopsy. Duration of response was an additional measure.
The notice lists a complete response rate of 62% (95% confidence interval: 51, 73). It says fifty-eight percent of patients with a complete response had a duration of response of 12 months or longer, and 40% had a duration of 24 months or longer.
Why the indication grew
The FDA notice says the approval is based on a review of available scientific information, extrapolating from the drug's earlier efficacy in CIS. It says high-grade papillary tumors and CIS have different architectural growth features, but both are considered aggressive urothelial carcinomas. The notice adds that they frequently coexist, can be difficult to tell apart under the microscope, and carry a high risk of recurrence and progression when BCG has stopped working.
Based on those overlapping clinical and non-clinical features, the FDA concluded that the earlier efficacy in patients with CIS could be extrapolated to patients with BCG-unresponsive high-grade papillary disease. The notice says the agency is working toward finalizing its guidance for industry on developing drugs for BCG-unresponsive NMIBC to address this approach.
Dose and safety in the notice
The notice lists a recommended dose of 400 mcg given into the bladder with BCG once a week for 6 weeks as induction. A second induction course is allowed if patients have residual CIS or high-grade Ta tumors at month 3. Maintenance is 400 mcg with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19, for a total of 15 doses. Patients with no evidence of high-grade disease at month 25 and later can receive BCG maintenance at months 25, 31 and 37, for a maximum of 9 additional instillations. The notice lists the criteria for stopping treatment: persistent disease after the second induction, recurrence or progression, or unacceptable toxicity. The maximum treatment duration is 37 months.
The most common adverse reactions, at 15% or more and including laboratory abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. The prescribing information carries a warning that delaying cystectomy can lead to metastatic bladder cancer, which can be lethal. The notice says full prescribing information will be posted on Drugs@FDA.