The FDA is reviewing information on a possible new treatment for papillary bladder cancer that does not respond to the standard treatment Bacillus Calmette-Guérin (BCG), according to an update published by the immunotherapy company ImmunityBio.
In papillary bladder cancer, the cancer is only in the lining of the bladder (not in the muscle layer), and usually appears as small growths shaped like mushrooms that grow out of the bladder lining.
The treatment developed by ImmunityBio uses the standard BCG treatment together with the medicine Anktiva, which works by helping the body’s immune system fight cancer. It activates certain immune cells that can find and destroy cancer cells and may help the body remember cancer cells, which could make the response last longer.
So far, the U.S. Food and Drug Administration (FDA) has approved the use of Anktiva+BCG to treat another type of non-muscle invasive bladder cancer that is unresponsive to BCG treatment.
Earlier in 2026, the FDA asked ImmunityBio to provide more information about how well the treatment works in papillary bladder cancer. The company sent the extra data, and the FDA has confirmed it received the new information and is reviewing it.
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Results from a clinical study of 80 patients with high-risk papillary bladder cancer showed promising outcomes. After one year, about 58% of patients had no sign of cancer. After three years, about 96% were still alive without dying from bladder cancer. The treatment also helped prevent the cancer from getting worse: After three years, more than 80% of patients were able to keep their bladder without needing removal surgery.
“The long-term data in papillary disease alone demonstrate prolonged disease-free survival and durable bladder preservation,” said Dr. Patrick Soon-Shiong, founder and global chief scientific and medical officer of ImmunityBio.
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