Novartis Gleevec first-line approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA approves Novartis' tyrosine kinase inhibitor Gleevec (imatinib) Dec. 20 for first-line treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia. Approval is based on 12-month data from the confirmatory International Randomized Study of Interferon vs. STI571 (IRIS) comparing Gleevec with the traditional CML regimen of interferon-alpha and cytosine arabinoside (Pharmaceutical Approvals Monthly, July 1, 2002, In Brief). Recently presented 18-month data showed an advantage in complete and major cytogenetic response and in progression-free survival. Data will be extrapolated to support a potentially imminent pediatric CML indicatio