Yeast-Derived GM-CSF (Leukine) Cleared for Use in Older AML Patients

SEATTLE-The FDA has granted Immunex Corporation marketing clearancefor Leukine (sargramostim), yeast-derived GM-CSF, for use in olderadult patients with acute myelogenous leukemia (AML) followinghigh-dose induction chemotherapy.

The agent was originally licensed in 1991 for use following autologousbone marrow transplantation in the treatment of certain cancers.

In a randomized, double-blind, placebo-controlled phase III studypresented to the FDA, Leukine was found to significantly decreaseearly mortality (death within 30 days of beginning AML treatment),as well as the incidence of life-threatening infections.

The multicenter study, conducted by the Eastern Cooperative OncologyGroup, evaluated 99 AML patients between the ages of 55 and 70who had not received previous chemotherapy or radiation therapy.

After administration of chemotherapy, the incidence of severe,life-threatening or fatal infections was significantly reducedin patients receiving Leukine (52% vs 74% in placebo patients).In addition, there were significantly fewer deaths from infectionsin patients receiving Leukine (6%), compared with placebo (23%).

Leukine significantly reduced early death (death on therapy orwithin 30 days of receiving placebo or Leukine) associated withchemotherapy for AML. Early death occurred in 28% of patientsreceiving placebo vs 8% of those on Leukine.

Data collected 6 months after therapy showed a mortality rateof 43% for placebo vs 17% for Leukine. The therapy was generallywell tolerated with mild side effects, the company said.