For people whose bladder cancer keeps coming back after BCG, the options have been narrow. On October 14, 2026, the U.S. Food and Drug Administration widened them. It expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln), used together with BCG, to adults with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) that is papillary-only. It is the first FDA approval to cover that group.
What changed
Anktiva was first approved in April 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. That left out patients whose disease was papillary-only, without CIS. The new label reads simply: Anktiva with BCG is indicated for adults with BCG-unresponsive non-muscle invasive bladder cancer. ImmunityBio, the company behind the drug, says access now extends to all patients with BCG-unresponsive NMIBC.
The numbers matter here. Papillary disease makes up roughly 85% of the NMIBC patient population, according to ImmunityBio, and NMIBC accounts for about 80% of bladder cancer diagnoses in the United States.
The evidence behind it
The trial did not test papillary-only patients directly. The FDA based its decision on a review of available scientific information, including earlier results in patients with CIS. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients reached a complete response (95% CI: 51, 73). Of those responders, 58% kept the response for at least 12 months and 40% for at least 24 months. The agency considered how closely CIS and high-grade papillary tumors resemble each other. Both can appear together, both are hard to tell apart under the microscope, and both can turn aggressive when BCG fails. The decision also sets out a new regulatory approach, in which evidence from closely related forms of bladder cancer can support expanded approvals.
Side effects and a warning
The most common treatment-related effects involve the bladder: painful urination, frequent urination and blood in the urine. Most were grade 1 to 2, which ImmunityBio says is consistent with BCG alone. The prescribing information carries a warning that delaying cystectomy, the surgical removal of the bladder, can allow metastatic cancer to develop, and that can be lethal. Anyone weighing a bladder-preserving route should talk it through with a urologist or cancer specialist, since surgery may still be the better call for some.
Market reaction
Investors took note. ImmunityBio shares (NASDAQ: IBRX) rose 1.12% to close at $9.91 on Wednesday, then added 0.81% to $9.99 in after-hours trading. Dr. Patrick Soon-Shiong, the company’s founder and executive chairman, called the approval “an important first step as we develop Immunotherapy 2.0.”
Sources
- FDA Expands Anktiva Approval for Bladder Cancer Patients
- FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
- ImmunityBio (IBRX) Stock: Climbs as FDA Expands ANKTIVA Approval for Bladder Cancer
