FDA approves Gleevec for gastrointestinal stromal cancer

WASHINGTON (Reuters Health) – Switzerland's Novartis AG said on Friday that it has received approval from the US Food and Drug Administration (FDA) to market its cancer therapy Gleevec (imatinib mesylate) for the treatment of gastrointestinal stromal cancer (GIST).

Gleevec was approved by the FDA in May 2001 for treatment of chronic myeloid leukemia. That approval garnered a great deal of public attention, in part because the drug was the first to be specifically designed to address an underlying genetic malfunction through a process called molecular targeting.

"In CML, Gleevec blocks the abnormal tyrosine kinase enzyme that plays a major role in that disease," the FDA said in a talk paper on Friday. "In GIST, Gleevec blocks a different abnormal enzyme found on the tumor cells. As these abnormal enzymes are largely confined to cancer cells, there is relatively little damage to normal cells."

Gleevec was approved for the new indication under the agency's accelerated approval and orphan drug programs.

The FDA said the open-label study on which it based the new approval enrolled 147 subjects with unresectable or metastatic GIST who received daily Gleevec therapy. "While no patient had compete disappearance of cancer, 56 patients (38%) had reduction in tumor size by 50% or greater," the agency said.

The duration of response to Gleevec has not yet been determined, the FDA cautioned. Under the accelerated approval program, Novartis is required to conduct postmarketing patient followup and other studies to measure Gleevec's real-world clinical benefit.

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