FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

FDA expanded approval of Anktiva with BCG to adults with BCG-unresponsive, high-grade papillary-only bladder cancer that has not invaded muscle. The agency says it relied on earlier evidence in carcinoma in situ and scientific similarities between the two forms of cancer.

Why it matters: FDA says applying evidence from carcinoma in situ to papillary-only disease may help guide future treatment development.