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FDA approves degarelix for advanced prostate cancer
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Today the FDA announced the approval of the gonadotropin-releasing hormone receptor inhibitor degarelix for the treatment of advanced prostate cancer. The injectable drug is the first new drug approved for prostate cancer in several years, according to the FDA.
The approval is based on data from a phase-3 clinical trial that compared degarelix (Ferring Pharmaceuticals Inc.) with leuprolide.
The randomized trial included 408 patients with histologically confirmed prostate cancer. Patients were randomly assigned to 240 mg degarelix subcutaneous injection for one month with monthly maintenance doses of 80 mg or monthly 7.5 mg intermuscular injections of leuprolide depot. The primary endpoint was testosterone suppression ≤50 ng/dL monthly from day 28 to day 364.
According to a press release, patients assigned to degarelix achieved suppression levels faster than those assigned to leuprolide; 96% of patients assigned to degarelix demonstrated a response at day three. None of the patients assigned to leuprolide demonstrated a response during that time, but instead 80% of patients assigned to leuprolide experienced a median 65% increase in testosterone levels at day three.
Injection site reactions such as pain, redness and swelling; hot flashes; increased weight; fatigue and increases in some liver enzymes were among the most commonly reported adverse events, according to the press release.