Eligard 7.5 mg (Leuprolide for Injection) Approved for Advanced Prostate Cancer

July 1, 2002

NEW YORK-Eligard 7.5 mg (leuprolide acetate for injectable suspension) is now commercially available for the palliative treatment of advanced prostate cancer, Sanofi-Synthelabo Inc. announced in a news release. The new formulation of the

NEW YORK—Eligard 7.5 mg (leuprolide acetate for injectable suspension) is now commercially available for the palliative treatment of advanced prostate cancer, Sanofi-Synthelabo Inc. announced in a news release. The new formulation of the luteinizing hormone-releasing hormone (LHRH) analog employs the Atrigel drug delivery system. Biodegradable polymers are mixed with the active drug and injected subcutaneously as a viscous liquid using a small-gauge needle. The liquid solidifies into a solid implant that slowly dissolves to release a continuous supply of the drug for a 1-month period.

The FDA approved Eligard based on an open-label, multicenter study of 120 patients with advanced prostate cancer treated with six monthly injections. Serum testosterone was suppressed to below the castrate threshold (50 ng/dL or less) by day 28 in 112 of 119 patients remaining in the study (94.1%). The other 7 patients all attained the castrate threshold by day 42.

At 6 months, all 117 patients who completed the study had testosterone levels at or below 50 ng/dL, including 115 who had levels at or below 20 ng/dL, the standard recommended by the National Comprehensive Cancer Network (NCCN) prostate cancer treatment guidelines, the company said. It noted that the clinical significance of achieving levels below 20 ng/dL is unknown.