The FDA has approved Novartis’ Gleevec (imatinib) tablets for the post-surgical treatment of adults following complete surgical removal of Kit (CD117)-positive gastrointestinal stromal tumors (GIST).

This approval was based on data from a Phase III double-blinded, randomized study that showed after a 14-month median follow-up, 91.6% of Gleevec patients remained cancer-free compared with 80.2% of those taking placebo.

Gleevec is already approved for nine indications, including the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML), Kit (CD117)-positive gastrointestinal stromal tumors which cannot be surgically removed and/or have already spread to other parts of the body and five other rare diseases.

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