FDA Expands Anktiva to a Narrow BCG-Unresponsive Bladder-Cancer Group
FDA expanded Anktiva with BCG to adults with high-grade papillary-only non-muscle-invasive bladder cancer that has not responded to BCG. The agency says this is the first approval specifically for that subgroup. The expansion extrapolates from a 77-patient study in carcinoma in situ, in which 62% had a complete response; among responders, 58% maintained it for at least 12 months and 40% for at least 24 months, together with clinical and laboratory similarities between the related diseases. It is not a universal bladder-cancer cure or a randomized survival result for the newly covered papillary-only population. Common harms include urinary symptoms, infection, fever and laboratory abnormalities, and the label warns that delaying bladder-removal surgery can allow fatal spread.
Article updated Oct 15, 2026, 9:07 AM Pacific
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