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FDA approves Novartis' Gleevec for CML

May 10, 2001 7:00 AM UTC

FDA announced Thursday its accelerated approval of Gleevec imatinib mesylate for the treatment of chronic myeloid leukemia (CML) from Novartis (NVS ; SWX:NOVN). The drug was developed in 32 months and the NDA was approved by FDA in 2-1/2 months. The approval covers three stages of CML: myeloid blast crisis, accelerated phase, and chronic phase after failure of interferon treatment. The accelerated approval was based on surrogate end points and is contingent on NVS conducting follow-up studies to confirm clinical benefit. ...