FDA Approves Degarelix to Treat Advanced Prostate Cancer

Ferring Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer. The drug will become available immediately after issuance of a trade name, which is currently under FDA review.

In phase III studies, degarelix was at least as effective as leuprolide (Lupron Depot) in sustaining castrate levels of testosterone, and significantly faster in reducing testosterone. At day 3 of treatment, 96% of degarelix patients achieved castrate levels of testosterone, compared with 0% on leuprolide. By day 14, 99% of degarelix patients achieved castrate levels, compared with 18% receiving leuprolide.

Degarelix is the only GnRH receptor antagonist approved by the FDA for the treatment of hormonally sensitive advanced prostate cancer.