CULVER CITY, Calif., October 14, 2026
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include adults with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary-only tumors. The expanded indication builds on the original April 2024 approval for patients with carcinoma in situ (CIS), with or without papillary tumors. With this decision, the approved indication covers adults with BCG-unresponsive NMIBC, including those with CIS, with or without papillary tumors, and those with papillary-only disease. ImmunityBio stated that papillary disease accounts for approximately 85% of the NMIBC patient population. The company describes this as the first FDA approval to include patients with BCG-unresponsive NMIBC whose disease consists only of papillary tumors. The expanded label broadens the population eligible for treatment with ANKTIVA plus BCG and adds a new FDA-approved treatment option for patients whose disease has not responded to BCG therapy.
Expanded Indication Broadens Treatment Access
The expanded FDA indication follows the agency’s April 2024 approval of ANKTIVA plus BCG for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The October 2026 decision extends the indication to include patients with papillary-only tumors, a group that has faced limited nonsurgical treatment options when high-grade disease becomes unresponsive to BCG. NMIBC represents approximately 80% of bladder cancer diagnoses in the United States, according to information cited in the company announcement. The disease includes CIS and papillary tumors, and an estimated 85% to 90% of patients diagnosed with NMIBC present with papillary disease, according to the cited source. Patients with BCG-unresponsive high-grade disease face risks of recurrence and progression, making additional treatment options an important consideration in clinical management. ImmunityBio Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong said the expanded approval advances the company’s goal of using the patient’s immune system to achieve durable, tumor-free outcomes. The company expects the broader indication to increase ANKTIVA’s addressable U.S. patient population and expand access for eligible patients across the BCG-unresponsive NMIBC spectrum.
Clinical Evidence and Safety Profile Support Approval
The expanded indication is based on the FDA’s review of available scientific information, including previously demonstrated efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response, with a 95% confidence interval of 51% to 73%. Among patients who achieved a complete response, 58% maintained that response for at least 12 months and 40% for at least 24 months. The company reported that the combination has a tolerable safety profile, with common treatment-related adverse events associated primarily with bladder instillation, including painful urination, increased urinary frequency and blood in the urine. Most of these events were Grade 1 or Grade 2 and were described as consistent with the side effects of BCG alone. The prescribing information includes an important warning that delaying cystectomy may allow bladder cancer to progress to muscle-invasive or metastatic disease, which can be fatal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, cystectomy should be reconsidered. ANKTIVA is for intravesical use only and must not be administered subcutaneously or intravenously. Its prescribing information also warns of potential fetal harm and identifies additional adverse reactions, including urinary tract infection, chills, fever, musculoskeletal pain and certain laboratory abnormalities.
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IL-15 Immunotherapy Platform Advances Bladder Cancer Care
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist designed to stimulate immune cells involved in recognizing and attacking cancer. Its structure combines an IL-15 mutant, IL-15N72D, with an IL-15 receptor alpha component in an IgG1 fusion complex. According to ImmunityBio, the medicine activates and supports the proliferation of natural killer (NK) cells and CD8-positive killer T cells, while promoting immune memory that may help sustain antitumor responses. The company’s broader Cancer BioShield platform is built around this immune-activation strategy and includes additional investigational approaches, such as adenovirus-vectored vaccines, allogeneic and autologous NK-cell therapies, and other immunomodulators. ImmunityBio President and Chief Executive Officer Richard Adcock said the expanded indication builds on commercial growth since the original approval and reflects the company’s focus on helping eligible patients access the treatment. Vanderbilt-Ingram Cancer Center Professor of Urology and Chief Surgical Officer Dr. Sam S. Chang also noted that an FDA-approved option for patients with BCG-unresponsive high-grade papillary disease adds to the treatment landscape. The expanded approval marks a regulatory milestone for ANKTIVA, while ongoing clinical decisions must continue to account for individual disease characteristics, treatment response and the risks associated with delaying surgery.
Source::ImmunityBio, press release
