Novartis Oncology announced today that Gleevec (imatinib mesylate) has been granted priority review by the U.S. Food and Drug Administration (FDA) for possible use as a first-line treatment for newly diagnosed patients with Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, the earliest stage of the disease.
The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alpha therapy failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. The FDA grants priority reviews to products for serious or life-threatening diseases that may offer a significant improvement compared to existing therapies.
Both applications submitted on June 28, 2002 were accepted for filing by the FDA. The priority review establishes an action date no later than six months after the filing date, or December 28, 2002. Gleevec was initially approved in May 2001 for the treatment of patients with Philadelphia chromosome-positive CML in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy.
The effectiveness of Gleevec is based on overall hematologic and Cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
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