Anktiva for Papillary Bladder Cancer: What Patients Should Know

For people with non-muscle invasive bladder cancer (NMIBC) that stops responding to Bacillus Calmette-Guérin (BCG), the next step has often been radical cystectomy, a major surgery to remove the bladder. An Oct. 14 decision from the Food and Drug Administration (FDA) gives more of these patients another option.

The FDA expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln) given with BCG to include adults with BCG-unresponsive NMIBC whose tumors are high-grade and papillary-only. Anktiva is placed directly into the bladder through a catheter, without major surgery.

The approval opens a bladder-sparing path for more people. Choosing it also means committing to years of treatment and follow-up, and understanding the risks of putting off surgery.

What does the expanded Anktiva approval change for people with bladder cancer?

Anktiva with BCG was already approved for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), a flat, aggressive type of tumor in the bladder lining, with or without papillary tumors. Papillary tumors grow outward from the bladder wall in finger-like shapes.

Until now, patients whose cancer was papillary-only, without CIS, did not have Anktiva as an approved option. The expanded approval changes that.

The FDA did not base this decision on a new trial. Instead, the agency reviewed available scientific information and noted that high-grade papillary tumors and CIS are both aggressive forms of urothelial carcinoma, a cancer that starts in the cells lining the urinary tract. The two tumor types often appear together, can be hard to tell apart under a microscope and both carry a high risk of coming back or progressing when BCG has stopped working.

That distinction matters for patients: the response data supporting Anktiva came from people with CIS. The FDA extended those findings to papillary-only disease based on the features the two tumor types share.

How well did Anktiva work in clinical trials?

The data come from Cohort A of the QUILT-3.032 trial, which included 77 patients with BCG-unresponsive, high-risk NMIBC with CIS, with or without papillary tumors.

In the trial, 62% of patients had a complete response, meaning cystoscopy (a camera exam of the bladder), urine cytology (a urine test that looks for cancer cells) and biopsy showed no signs of cancer. Among those who had a complete response, 58% had a response lasting 12 months or longer, and 40% had a response lasting 24 months or longer.

QUILT-3.032 was a single-arm trial, meaning every patient received Anktiva with BCG and there was no comparison group.

How long does Anktiva treatment take?

Anktiva is a long-term commitment. Treatment begins with an induction phase: Anktiva with BCG placed into the bladder once a week for six weeks. Patients who still have CIS, high-grade Ta tumors or both at month 3 may receive a second induction course.

Maintenance treatment follows, with weekly instillations for three weeks at months 4, 7, 10, 13 and 19, for a total of 15 doses. Patients with no evidence of high-grade disease at month 25 and later may continue maintenance at months 25, 31 and 37, for up to nine more instillations.

Total treatment can last up to 37 months. Along the way, patients can expect repeated clinic visits, cystoscopies and urine tests to check whether the cancer has responded.

Treatment is stopped if cancer remains after a second induction course, if it comes back or progresses, or if side effects become too difficult to manage.

What are the risks of delaying bladder removal surgery?

Keeping the bladder is the main benefit of Anktiva, but it is not without risk. The prescribing information warns that delaying cystectomy can allow bladder cancer to spread to other parts of the body, and metastatic bladder cancer can be fatal.

For that reason, choosing Anktiva should be a shared decision between patients and their care team, made with a clear understanding of what happens if the cancer does not respond or comes back.

What side effects can Anktiva cause?

The most common side effects, reported in at least 15% of patients and including changes seen in lab tests, were:

• Increased creatinine, a marker of kidney function
• Painful urination
• Blood in the urine
• Frequent urination
• An urgent need to urinate
• Urinary tract infection
• Increased potassium
• Muscle and bone pain
• Chills
• Fever

What questions should patients ask their care team about Anktiva?

People considering Anktiva may want to ask:

• Is my cancer papillary-only, or does it include CIS?
• What are the benefits and risks of Anktiva compared with bladder removal in my situation?
• How often will I need to come in for treatment and checkups, and for how long?
• What signs would mean the treatment isn’t working, and what would we do next?
• What side effects should I report right away?

Reference

1. “FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer.” U.S. Food and Drug Administration. Posted: Oct. 14, 2026.

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