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FDA Expands Anktiva Approval for Bladder Cancer That Resists BCGLongevity & Aging

FDA Expands Anktiva Approval for Bladder Cancer That Resists BCG

Anktiva plus BCG has gained expanded FDA approval for adults with aggressive, finger-like bladder tumors that have not invaded the bladder muscle and have resisted BCG treatment. The decision draws on an earlier trial involving 77 adults with a related, flat form of bladder cancer, some of whom also had finger-like tumors. In that trial, 62% had no detectable high-grade cancer after treatment. Among responders, 58% maintained that response for at least one year and 40% for at least two years. The FDA applied these findings to the newly eligible group because the cancers share important biological and clinical features. Treatment goes directly into the bladder through a catheter. Patients should discuss eligibility, alternatives, monitoring, and side effects with their specialist; the announcement does not establish a survival benefit.

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