Anktiva Plus BCG Resubmitted to FDA for Papillary Bladder Cancer

ImmunityBio has resubmitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with papillary tumors, according to a news release from the company.

The resubmission follows discussions between the company and the FDA after the agency requested additional data to support the application. ImmunityBio provided updated information in February 2026, and the FDA acknowledged receipt of the resubmitted filing after reviewing the additional materials. Importantly, the agency did not request new clinical trials during the process.

If approved, the expanded indication could provide a new treatment option for patients whose bladder cancer no longer responds to BCG therapy and who have papillary tumors without carcinoma in situ. For many patients, these cases are particularly challenging because treatment options become limited after BCG failure, and radical cystectomy (surgical removal of the bladder) is often recommended.

FDA review continues for Anktiva plus BCG in papillary NMIBC

The resubmission marks an important step in ImmunityBio’s effort to expand the use of Anktiva in bladder cancer. The therapy is already approved in the United States in combination with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.

The current regulatory submission aims to extend the treatment’s use to patients who have papillary tumors without CIS. This group of patients represents a significant portion of individuals with BCG-unresponsive NMIBC, and approval could expand the number of patients eligible for bladder-preserving immunotherapy.

According to the company, the FDA’s request for additional information focused on updated efficacy and follow-up data from ongoing studies evaluating the combination therapy. The resubmission includes these updated findings for the agency’s review.

Understanding BCG-unresponsive NMIBC

NMIBC refers to tumors that remain confined to the inner lining of the bladder and have not spread into the bladder muscle. BCG therapy, a type of immunotherapy delivered directly into the bladder, is often used as a standard treatment to prevent recurrence or progression of this disease.

However, some patients eventually develop BCG-unresponsive disease, meaning the cancer persists or returns despite treatment. At that stage, treatment choices become more limited, and physicians may recommend radical cystectomy as a potentially curative approach.

Because bladder removal can significantly affect quality of life, researchers have been investigating therapies that may control cancer while preserving the bladder. Anktiva, an immunotherapy designed to stimulate immune system activity, is one such approach under study.

Clinical data supporting the resubmission

The resubmitted application is supported by findings from the QUILT-3.032 study, which evaluated Anktiva plus BCG in patients with BCG-unresponsive NMIBC. Long-term follow-up data have shown encouraging outcomes among patients with papillary disease. Among patients treated with the combination therapy, disease-specific survival was reported at 96% after 36 months of follow-up, and the median disease-specific survival had not yet been reached.

Investigators also observed strong progression-free survival rates. At 12 months, approximately 94.9% of patients remained free from progression to muscle-invasive disease, and 83.1% maintained progression-free status at 36 months.

These findings suggest the treatment may help delay or prevent disease progression for many patients.

Patients enrolled in studies evaluating Anktiva plus BCG had disease that continued to recur or persist after receiving adequate BCG treatment. The goal of the therapy is to stimulate immune responses in the bladder that help eliminate cancer cells and prevent recurrence.

What comes next

Long-term analyses from clinical trials suggest that treatment with Anktiva plus BCG may help many patients avoid or delay radical cystectomy, allowing them to preserve bladder function. Because bladder removal surgery carries significant physical and emotional impacts, therapies that offer durable disease control while maintaining the bladder are of particular interest to both patients and clinicians.

With the resubmission now acknowledged by the FDA, the agency will continue reviewing the updated data package. If approved, the expanded indication could offer a new immunotherapy option for patients with BCG-unresponsive NMIBC with papillary tumors.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

References

1. “ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data,” by ImmunityBio. News release; March 9, 2026.

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