The Lynx Group

FDA Updates Imatinib's Label to 36 Months of Use after Removal of GIST

March 2012, Vol 3, No 2

The US Food and Drug Administration (FDA) approved an updated label for imatinib (Gleevec; Novartis) for the use of the drug in adults after the surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The FDA now recommends extending treatment with imatinib to 36 months instead of the current standard of 12 months. This approval, processed under a priority review, highlights the new data from a phase 3 clinical trial showing an increased overall survival (OS) in patients using imatinib for 36 months compared with 12 months.

The use of the drug for 36 months significantly reduced (by 54%) relapsefree survival compared with the 12- month use (P <.001). In addition, 36 months of treatment reduced the risk of death by 55% compared with 12 months of treatment. The median time of follow-up was 42 months for relapse-free survival and 48 months for OS. At 60 months, 92% of patients who received 36 months of imatinib were alive compared with 82% of those who received the drugs for 12 months. "Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patients' lives in earlier disease settings," said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA. (January 31, 2012)

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