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FDA Adds Longer GIST Therapy to Imatinib Label
FDA Adds Longer GIST Therapy to Imatinib Label
E Mechcatie
20120101
2012 Feb 1
Elsevier Global Medical News
FDA Adds Longer GIST Therapy to Imatinib Label
Elsevier Global Medical News. 2012 Feb 1, E Mechcatie
Clinical trial data showing a significant increase in survival when imatinib is used for 3 years as adjuvant therapy after resection of Kit-positive gastrointestinal stromal tumors has been added to the drug's label.The change "highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment," the Food and Drug Administration said in a Jan. 31 statement.The agency also announced the granting of "regular" approval to imatinib (Gleevec)...