SEATTLE-The FDA has granted Immunex Corporation marketing clearance for Leukine (sargramostim), yeast-derived GM-CSF, for use in older adult patients with acute myelogenous leukemia (AML) following high-dose induction chemotherapy.
The agent was originally licensed in 1991 for use following autologous bone marrow transplantation in the treatment of certain cancers.
In a randomized, double-blind, placebo-controlled phase III study presented to the FDA, Leukine was found to significantly decrease early 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 Oncology Group, evaluated 99 AML patients between the ages of 55 and 70 who had not received previous chemotherapy or radiation therapy.
After administration of chemotherapy, the incidence of severe, life-threatening or fatal infections was significantly reduced in patients receiving Leukine (52% vs 74% in placebo patients). In addition, there were significantly fewer deaths from infections in patients receiving Leukine (6%), compared with placebo (23%).
Leukine significantly reduced early death (death on therapy or within 30 days of receiving placebo or Leukine) associated with chemotherapy for AML. Early death occurred in 28% of patients receiving placebo vs 8% of those on Leukine.
Data collected 6 months after therapy showed a mortality rate of 43% for placebo vs 17% for Leukine. The therapy was generally well tolerated with mild side effects, the company said.