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."