FDA Logo Gastrointestinal stromal tumors (GIST) is a rare kind of cancer occurring along the sides of the gastrointestinal tract (GI). More recently, the US Food and Drug Administration (FDA) approved of the drug namely Gleevec for use among adult GIST patients after CD117-positive gastrointestinal stromal tumors (GIST) have been taken off surgically.

The aforesaid drug was originally approved for use in the metastatic form of this cancer, however this regular approval allows for its long term use. About 82% of GIST patients receiving 12 months of Gleevac seemed to survive after a span of 60 months. On the other hand, nearly 92% of patients treated with the drug for 36 months survived in the absence of disease recurrence.

“The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits. Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of Gleevec can prolong patient’s lives in earlier disease settings,” commented Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Gleevac is a tablet that is supposed to be consumed with a glass of water and a meal. The most common side-effects reported were muscle cramps, nausea, swelling, bone or muscle pain, vomiting, fatigue, rash, diarrhea and abdominal pain. This drug was initially approved for treatment of advanced Philadelphia chromosome positive chronic myeloid leukemia in May 2001. With the present approval, the label of Gleevec has been extended to include 36 months of treatment.

Gleevec is sold by Novartis Pharmaceuticals.