FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
read at fda press ↗ApprovalPositive
The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that has not responded to BCG.
This approval is the first specifically for BCG-unresponsive high-grade papillary disease and builds on earlier clearance of Anktiva for carcinoma in situ.
The agency said the decision reflects a new approach of using data from similar tumor types to expand treatment options and may guide future drug development.
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This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer”
read at fda press ↗697 words · retrieved 1h ago
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