Sanofi-Synthelabo announced the commercial availability of Eligard (leuprolide acetate, 7.5 mg) for the palliative treatment of advanced prostate cancer at the 2002 annual meeting of the American Urological Association. Recommended in the prostate cancer treatment guidelines of the National Comprehensive Cancer Network (NCCN), leuprolide suppresses testosterone to beyond traditional castration levels. The 1-month formulation, which was recently approved by the US Food and Drug Administration, uses the Atrigel delivery system to provide continuous release of leuprolide over a 1-month period. When mixed with a drug and injected into the body, Atrigel solidifies and forms a small implant that slowly dissolves, thereby releasing the drug into the body.
Study Confirms Efficacy
In an open-label, multicenter study, 120 patients with advanced prostate cancer (89 had stage C disease, 31 had stage D) received monthly injections of Eligard, 7.5 mg, for 6 months. The study evaluated the achievement and maintenance of serum testosterone suppression over 6 months of therapy. Serum testosterone was suppressed to below ≤ 50 ng/dL by day 28 (week 4) in 112 of 119 (94.1%) patients. The remaining seven patients attained serum testosterone suppression by day 42. At the conclusion of the study, all 117 patients who completed the study had testosterone levels at or below 50 ng/dL.
The most common adverse effects reported in this investigation were hot flashes/sweats; a total of 86 such events occurred in 70 patients. Of these, 71 events (83%) were mild, and 14 (1%) were severe.
"Many advances have been made in the hormonal treatment of prostate cancer," said A. Oliver Sartor, MD, director of the Stanley S. Scott Cancer Center at Louisiana State University Medical School in New Orleans. "In particular, Eligard, 7.5 mg, utilizes a new delivery system for a proven drug that has been used in prostate cancer for more than a decade. This delivery system has proven to deliver leuprolide acetate over a 30-day period in a manner that results in a consistently very low level of testosterone, thereby helping to optimally manage this difficult disease."