FDA Adds Five New Indications and One Precaution to Gleevec

ROCKVILLE, Md., Oct. 20 -- The FDA has extended the approval of Gleevec (imatinib mesylate), an oral tyrosine kinase inhibitor, to five new indications, all rare life-threatening disorders.

At the same time, the FDA appended a Gleevec label change about congestive heart failure. Gleevec was approved in May 2001 for treating Philadelphia-chromosome-positive chronic myelogenous leukemia (CML) and later for gastrointestinal stromal tumor (GIST).

The new indications, all second-line, included dermatofibrosarcoma protuberans, a solid tumor that typically presents as a hard lump in the skin of the chest, abdomen, or leg.

Others are for hematologic diseases. They are:

• Relapsed or refractory Philadelphia-chromosome-positive acute lymphoblastic leukemia (ALL), a rapidly progressive disease;
• Myelodysplastic/myeloproliferative diseases;
• Hypereosinophilic syndrome/chronic eosinophilic leukemia, which is characterized by persistent overproduction of eosinophils; and
• Aggressive systemic mastocytosis, also known as aggressive mast cell disease.

The FDA approved Gleevec for refractory or resistant forms of these diseases. Novartis, which makes Gleevec, said the FDA is still reviewing the drug for treatment of newly diagnosed patients with these disorders.

The FDA also announced changes to the precautions section of the Gleevec label describing the occasional occurrence of severe congestive heart failure. The label change notification followed by two weeks an announcement from Novartis that detailed the revisions.