The FDA approved a first treatment for a hard-to-treat bladder cancer
The FDA expanded Anktiva, given with BCG, to adults with BCG-unresponsive high-grade papillary-only bladder cancer. A related trial, not this exact group, saw a 62 percent complete response.
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On Oct. 14, 2026, the Food and Drug Administration approved Anktiva, given with BCG, for adults with BCG-unresponsive high-grade papillary-only bladder cancer. The agency described it as the first treatment approved for that group.
The decision drew on a trial in a closely related form of the disease, carcinoma in situ, in which 62 percent of patients had a complete response. That figure is from the carcinoma in situ trial. It is not a result measured in the papillary-only patients covered by this expansion. Common side effects occur. The approval is not a promise that every patient will respond, and it is not a statement that the cancer is cured.
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