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.