New Bladder Cancer Treatment Options Could Expand
The FDA may review expanded uses for Anktiva, which has shown a 71% response rate in ongoing clinical trials.
Updated on Oct. 27, 2026 in Cancer
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ImmunityBio is preparing to submit data to the FDA in late 2026 to expand the use of its drug Anktiva for bladder cancer treatment. This development follows recent clinical findings showing high response rates among patients with non-muscle invasive bladder cancer.
Why it matters
Expanding treatment options for bladder cancer remains a priority for patients, particularly those seeking to avoid surgery. The company's upcoming trial results may provide further evidence on the long-term effectiveness of adding Anktiva to standard BCG therapy.
A study involving 366 patients with non-muscle invasive bladder cancer reported a 71% complete response rate for the combination of Anktiva and BCG. Among those who responded, 84% remained free from bladder-removal surgery after three years, though results from the latest trial are pending.
The players
ImmunityBio
A biotechnology company focused on developing immunotherapies, including Anktiva, for cancer treatment.
FDA
The federal agency responsible for overseeing the safety and efficacy of medical treatments in the United States.
The details
Anktiva is designed to work in conjunction with BCG, a standard immunotherapy for bladder cancer, to stimulate the immune system's response against tumor cells. Researchers are evaluating this combination against BCG therapy alone to determine if it can improve survival rates and reduce the need for cystectomy. The company is currently finalizing data from a trial comparing the two treatment regimens to support its regulatory application.
Timeline
August 2026: Eli Lilly agreed to acquire Merida Biosciences.
September 2026: AbbVie completed its acquisition of Apogee Therapeutics.
October 2026: The FDA expanded Anktiva approval for papillary-only bladder tumors.
November 2026: ImmunityBio expects results from its 366-patient trial.
Fourth quarter 2026: ImmunityBio plans to submit an application for expanded FDA approval.
Health Landscape
The clinical pursuit of Anktiva reflects an ongoing effort to improve the standard of care for non-muscle invasive bladder cancer by enhancing the efficacy of existing immunotherapies. This approach sits within a broader trend of leveraging novel drug combinations to reduce the need for invasive surgeries.
Patients currently managing non-muscle invasive bladder cancer should stay informed about potential new treatment protocols involving BCG and immunotherapy combinations. It is a topic worth discussing with a urologist or oncologist during routine checkups to understand how emerging data might influence future care plans.
The takeaway
The addition of newer immunotherapy agents to traditional bladder cancer treatments is an area of active clinical investigation aimed at improving long-term surgical avoidance. Patients should follow updates on approved treatment regimens and maintain regular consultations with their specialized care team.
What happens next
ImmunityBio expects to release findings from its 366-patient trial in November 2026 and plans to submit an FDA application by the end of the fourth quarter of 2026.
Further reading
For more information on current treatment strategies, visit our Cancer section.
Source note: This article includes information reported by Asianet News Network Pvt Ltd.
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