Gleevec approved to treat post-surgical GI stromal tumors

GLEEVEC (imatinib as mesylate) 100mg, 400mg tablets by Novartis
GLEEVEC (imatinib as mesylate) 100mg, 400mg tablets by Novartis

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.

For more information call (888) 669-6682 or visit www.gleevec.com.