FDA Expands Anktiva Approval for BCG-Unresponsive Bladder Cancer to Include Papillary-Only Disease

The FDA expands Anktiva approval with BCG for BCG-unresponsive non-muscle-invasive bladder cancer, including papillary-only tumors.

FDA Broadens Anktiva Approval for Non-Muscle-Invasive Bladder Cancer

ImmunityBio, Inc. has announced an expanded U.S. Food and Drug Administration (FDA) approval for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). Announced on October 14, 2026, the expanded indication now includes patients with papillary-only tumors, extending treatment eligibility beyond the previously approved population with carcinoma in situ (CIS), with or without papillary tumors.

The decision represents a significant development in the treatment landscape for patients whose bladder cancer does not respond adequately to BCG therapy. It also makes Anktiva plus BCG the first FDA-approved treatment option specifically to include BCG-unresponsive NMIBC with papillary-only tumors.

What Does the Expanded FDA Approval Mean?

Non-muscle-invasive bladder cancer is a form of bladder cancer that has not grown into the bladder's muscular wall. It includes different types of tumors, such as carcinoma in situ and papillary tumors.

Carcinoma in situ is a flat, high-grade form of cancer affecting the lining of the bladder. Papillary tumors are abnormal growths that extend into the bladder's interior. Some patients have both types of disease, while others have papillary tumors without CIS.

Before this latest expansion, Anktiva in combination with BCG was FDA-approved in April 2024 for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The expanded indication now covers adults with BCG-unresponsive NMIBC, including patients with papillary-only disease.

According to ImmunityBio, papillary disease represents approximately 85% of the NMIBC patient population. The expanded indication therefore addresses a broader group of patients who may need additional treatment options when their cancer no longer responds to BCG.

However, eligibility for treatment must be determined by a qualified healthcare professional based on the patient's diagnosis, prior treatment, disease characteristics, and the approved prescribing information.

Why BCG-Unresponsive Bladder Cancer Is a Significant Concern

BCG is an established treatment used in certain cases of NMIBC. It stimulates an immune response in the bladder and is commonly used to reduce the risk of cancer recurrence and progression in appropriate patients.

Some patients, however, continue to experience high-grade disease despite BCG treatment. This is known as BCG-unresponsive bladder cancer.

For these patients, the risk of recurrence and progression remains an important clinical concern. Treatment decisions can become particularly challenging when patients have high-grade papillary tumors that persist or return after BCG therapy.

Historically, nonsurgical treatment options for certain patients with BCG-unresponsive disease have been limited. The expanded Anktiva indication introduces another FDA-approved option for eligible adults with papillary-only NMIBC, potentially broadening the choices available during treatment discussions with their urologists.

Bladder preservation may be an important consideration for some patients. Nevertheless, preserving the bladder must be balanced against the risk of cancer progression and the potential consequences of delaying surgery.

How Anktiva Works With BCG

Anktiva is an interleukin-15 (IL-15) receptor agonist designed to stimulate components of the body's immune system. It is administered in combination with BCG and is intended to support immune activity against cancer cells.

IL-15 plays an important role in the development and function of natural killer (NK) cells and CD8-positive killer T cells. These immune cells participate in identifying and attacking abnormal cells, including cancer cells.

Anktiva is designed to activate and expand these immune cell populations. Its mechanism also aims to support the development of immune memory, which may contribute to sustained immune responses.

The combination of Anktiva and BCG represents an immunotherapy approach that works through immune system activation rather than relying solely on conventional cancer treatment methods.

The expanded FDA indication reflects the agency's review of available scientific information, including previously demonstrated efficacy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors.

Clinical Evidence Supporting Anktiva

The FDA's expanded approval was based on its review of available scientific information, including results from the QUILT-3.032 clinical trial.

In Cohort A of the study, 62% of 77 patients achieved a complete response. A complete response means that no evidence of disease meeting the relevant response criteria was detected at the assessment.

Among patients who achieved a complete response, 58% maintained that response for at least 12 months, while 40% maintained it for at least 24 months.

These results provide important context for understanding the clinical evidence supporting Anktiva in the previously approved CIS population. They should not be interpreted as separate efficacy estimates for patients with papillary-only tumors, because the reported figures relate to Cohort A and do not establish a distinct response rate for the newly included group.

Individual outcomes can vary, and treatment decisions should take into account the complete clinical evidence, the patient's condition, and the prescribing information.

Safety Information and Important Treatment Considerations

According to ImmunityBio, the combination of Anktiva and BCG has a tolerable safety profile, with common treatment-related adverse events associated with bladder instillation. Reported events include painful or difficult urination, increased urinary frequency, and blood in the urine. Most of the treatment-related events described in the announcement were mild to moderate in severity.

The prescribing information also identifies other potential adverse reactions, including urinary urgency, urinary tract infections, chills, fever, musculoskeletal pain, and certain laboratory abnormalities.

An important warning concerns delaying cystectomy, which is the surgical removal of the bladder. Delaying cystectomy in patients with BCG-unresponsive NMIBC can allow the disease to progress to muscle-invasive or metastatic bladder cancer, which can be life-threatening.

The prescribing information advises clinicians to reconsider cystectomy if high-grade disease remains evident after a second induction course of Anktiva with BCG.

Patients should discuss the potential benefits, risks, alternative treatments, and appropriate monitoring with their healthcare team. Anktiva is intended for intravesical administration and should not be administered intravenously or subcutaneously.

What the Expanded Approval Could Mean for Patients

The expanded approval increases the number of patients who may be eligible for Anktiva plus BCG in the United States. By including papillary-only disease, the indication addresses an important population with historically limited nonsurgical treatment choices.

For patients and clinicians, the decision creates an opportunity to evaluate an additional approved treatment option within an individualized care plan.

The announcement also highlights the continuing role of immunotherapy research in bladder cancer. Further clinical experience and ongoing safety monitoring will help build understanding of treatment outcomes across the broader approved population.

Patients should consult their urologist or oncology team to determine whether Anktiva plus BCG is appropriate for their specific diagnosis and circumstances.

Conclusion

The FDA's October 2026 expansion of Anktiva approval marks an important regulatory development for adults with BCG-unresponsive non-muscle-invasive bladder cancer. By including papillary-only tumors, the expanded indication broadens access to an immunotherapy option previously approved for patients with CIS, with or without papillary tumors.

Although the decision provides another treatment option for eligible patients, it does not eliminate the risks associated with BCG-unresponsive disease. Careful evaluation, discussion of treatment alternatives, and timely consideration of surgery remain essential parts of clinical decision-making.

As research and clinical experience develop, Anktiva may continue to play a role in the evolving treatment landscape for non-muscle-invasive bladder cancer.

Disclaimer

This article is for informational and educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. It is based on information provided by ImmunityBio in its October 14, 2026, announcement and should not replace the official FDA-approved prescribing information or guidance from a qualified healthcare professional. Treatment suitability, potential benefits, risks, and alternatives vary by patient. Patients should consult their healthcare provider before making decisions about bladder cancer treatment. The reported clinical trial results relate to the specific study population described and should not be assumed to predict outcomes for every patient or for all newly included patient groups.