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

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.