HealthDay News — The FDA has approved anti-cancer drug imatinib (Gleevec, Novartis) to treat children newly diagnosed with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL).
Previously, the drug was first approved as a first-line treatment for Ph-positive chronic myeloid leukemia in children, as well as for multiple indications in adults.
Ph-positive ALL progresses rapidly if left untreated. Imatinib belongs to a class of drugs called tyrosine kinase inhibitors and blocks proteins that promote development of cancer cells, the FDA said in a news release.
The new approval was based on results of a clinical trial that involved 92 children, who were into five groups to receive different durations of imatinib therapy along with conventional chemotherapy.
Among the 50 children assigned to the longest duration of imatinib, the 4-year progression-free survival rate was 70%. Increasing duration of imatinib therapy was associated with lower overall mortality, the FDA said.
Common side effects include neutropenia, thrombocytopenia, increased infections and liver toxicity.