FDA: Gleevec (Imatinib) Approved for Pediatric Ph+ ALL
FDA: Gleevec's Latest Approval Is for Pediatric Cancer
(HealthDay News) -- The anti-cancer drug Gleevec (imatinib) has received new U.S. Food and Drug Administration approval to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL), the agency said Friday.
Ph+ ALL progresses rapidly if left untreated. Gleevec, among a class of drugs called tyrosine kinase inhibitors, blocks proteins that promote development of cancer cells, the FDA said in a news release.
The most common side effects observed in pediatric testing included infection and a decrease in white blood cells and blood platelets.
Gleevec was first approved in 2001 to treat a form of chronic myeloid leukemia, and has since been approved to treat several other conditions. The drug is marketed by Novartis, based in East Hanover, N.J.