On October 14, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported 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 patients with BCG-unresponsive NMIBC with papillary-only tumors.
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The expanded FDA label reads as follows: Anktiva, in combination with Bacillus Calmette-Guérin (BCG), is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer.2
The broadened indication builds on the FDA’s April 2024 approval of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS).3 with or without papillary tumors. CIS and papillary tumors are aggressive and associated with high risk of recurrence and progression in the BCG-unresponsive setting. This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors.
"This approval marks an important expansion of ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient’s own immune system to achieve durable, tumor-free outcomes," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "An important first step as we develop immunotherapy 2.0."
The expanded approval is based on the FDA’s review of available scientific information, including the 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 (95% CI: 51, 73); among responders, 58% maintained a response for at least 12 months and 40% for at least 24 months.4
The combination of ANKTIVA plus BCG has a tolerable safety profile, with the most common treatment-related adverse events (TRAEs) related to bladder instillation (e.g., dysuria, pollakiuria, and hematuria), and most of these TRAEs were grade 1 to 2. This is consistent with the side effects of BCG alone.4 The prescribing information includes a warning that delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal.2
Expanding Treatment Options for BCG-Unresponsive NMIBC
Bladder cancer has among the most expensive cancers to treat over a patient’s lifetime, reflecting the substantial costs associated with ongoing surveillance, treatment, and disease management.5 NMIBC accounts for approximately 80% of all bladder cancer diagnoses in the U.S. and includes both CIS and papillary tumors.6 An estimated 85% to 90% of patients diagnosed with NMIBC present with papillary disease.7 Patients with high-grade papillary disease that becomes unresponsive to BCG face an increased risk of recurrence and progression and often have limited nonsurgical treatment options.
"Patients with high-grade papillary disease that no longer responds to BCG remain at meaningful risk for recurrence and progression and historically have had limited nonsurgical treatment options," said Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. "The availability of an FDA-approved treatment for this population represents an important addition to the treatment landscape, providing appropriate patients with BCG-unresponsive disease another treatment option that may help preserve the bladder."
ANKTIVA’s expansion into BCG-unresponsive high-grade papillary-only NMIBC significantly increases its U.S. addressable patient population beyond the currently approved CIS with or without papillary indication.
"The expansion of ANKTIVA plus BCG into papillary-only disease broadens the eligible patient population and establishes it as the first FDA-approved therapy for both CIS and papillary-only disease in BCG-unresponsive NMIBC," added Richard Adcock, President and CEO of ImmunityBio. "Building on strong commercial growth since ANKTIVA’s initial approval, we remain focused on helping eligible patients access this therapy and are grateful to the patients, families, investigators, and clinical teams who made this progress possible."
About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA at Anktiva.com.
(Press release, ImmunityBio, OCT 14, 2026, View Source [SID1234673436])