Steba’s Tookad: US FDA Panel To Weigh Novel Endpoints, Missing Data And Toxicities

 
• By Sue Sutter

Sponsor seeks accelerated approval for low-risk, early-stage prostate cancer based on a trial that met its coprimary endpoints, but agency says interpretation of those results is complicated by novelty of the outcomes, data quality issues and increase in genitourinary adverse events.

Prostate cancer, 3D illustration showing presence of tumor inside prostate gland which compresses urethra
Steba is seeking accelerated approval for low-risk, early-stage prostate cancer, but US FDA may want more data. • Source: Shutterstock

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