Gleevec Gets FDA Priority Review for First-Line Use in Early CML

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Oncology NEWS InternationalOncology NEWS International Vol 11 No 10
Volume 11
Issue 10

EAST HANOVER, New Jersey-Novartis Oncology’s Gleevec (ima-tinib mesylate) has been granted priority review by the FDA for use as first-line treatment for newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alfa failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. Both applications will be decided by December 28, 2002, the company said in a news release.

EAST HANOVER, New Jersey—Novartis Oncology’s Gleevec (ima-tinib mesylate) has been granted priority review by the FDA for use as first-line treatment for newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alfa failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. Both applications will be decided by December 28, 2002, the company said in a news release.

Articles in this issue
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Vaccine Turns Immune System Against Cancer Cells
Three Themes to Guide von Eschenbach at NCI
Arimidex Approved for Early-Stage Breast Cancer in Postmenopausal Pts
Long-Term Exposure to Diesel Exhaust Poses Lung Cancer Risk
Most Americans Unaware of Excessive Weight as a Risk for Some Cancers
Three Themes to Guide von Eschenbach as NCI Director
Gleevec Gets FDA Priority Review for First-Line Use in Early CML
New Anti-HIV Agent Prevents Virus From Entering Cell
Docetaxel/Gemcitabine Effective in Advanced NSCLC
Infusional FUFOX: Better PFS in Advanced Colorectal Cancer
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Ductal Lavage Identifies Patients for Chemoprevention
Bone Mineral Deficits Seen After Childhood Allogeneic BMT
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