NEW YORKEligard 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.