FDA Refuses to File Anktiva Application for BCG-Unresponsive Bladder Cancer

The Food and Drug Administration (FDA) issued a Refusal to File letter regarding a biologics license application for Anktiva. The application concerned the use of Anktiva in patients who have BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. This action occurred even though the FDA had previously encouraged the submission of this supplemental application. The company hoped Anktiva would be used for this specific patient population, but the FDA declined to move forward with reviewing it at this time.

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Date: May 6, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後