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

24 Feb 2020

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

Steba Biotech S.A.’s prostate cancer therapy Tookad (padeliporfin di-potassium powder) is heading into a US Food and Drug Administration advisory committee review on 26 February amid agency questions about novel clinical trial endpoints, missing data and toxicity.

In a briefing document released 24 February, the agency asks the Oncologic Drugs Advisory Committee to consider whether the...