News / 17 October 2026

FDA expands Anktiva approval to BCG-unresponsive high-grade papillary-only bladder cancer

17 October 2026 · Based on: U.S. Food and Drug Administration

The Food and Drug Administration (FDA) has expanded the approved use of Anktiva, given with BCG, to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment.^[1] The agency describes Anktiva as the first FDA-approved treatment specifically for this group of patients.^[1]

The FDA says the approval marks a new approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).^[1] It based its decision on the evidence behind an earlier Anktiva approval for carcinoma in situ (CIS), with or without papillary tumors, and on scientific similarities between CIS and high-grade papillary-only disease.^[1] The approval was granted to Altor BioScience, LLC.^[1]

The earlier CIS approval was supported by a trial (NCT03022825) in 77 adults, some of whom also had papillary tumors.^[1] Sixty-two percent achieved a complete response, meaning no high-grade cancer was detected during follow-up assessments.^[1] Of those, 58% maintained the response for at least 12 months and 40% for at least 24 months.^[1]

For the expanded approval, the FDA considered these results alongside clinical and laboratory evidence that CIS and high-grade papillary tumors share important features.^[1] It says they often occur together, can be difficult to distinguish under a microscope and carry a high risk of returning or progressing when BCG treatment no longer works.^[1] Angelo de Claro, Director of the FDA's Oncology Center of Excellence, said the review allowed the agency to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone.^[1]

Anktiva is given with BCG directly into the bladder through a catheter, once a week for six weeks, with additional treatment based on how the cancer responds.^[1] Treatment may continue for up to 37 months.^[1] The most common side effects included painful or frequent urination, blood in the urine and urinary tract infections.^[1] The prescribing information warns that delaying surgery to remove all or part of the bladder can allow the cancer to spread, which can be fatal.^[1]

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