FDA Reviewers Skeptical of GSK’s sNDA for Avodart to Prevent Prostate Cancer

FDA reviewers have thrown cold water on GlaxoSmithKline’s (GSK) hopes of gaining an indication for Avodart to reduce the risk of developing prostate cancer, citing “major issues” with the company’s application. In briefing documents released ahead of the Dec. 1 meeting of the Oncologic Drugs Advisory Committee, the FDA questioned the relevance of GSK’s clinical trial results submitted in support of its sNDA for Avodart (dutasteride), now approved for the treatment of benign prostate enlargement. No drugs are FDA-approved for prevention of prostate cancer.
Drug Industry Daily