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FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

Confirmatory trials show significantly prolonged survival in patients; drug granted regular approval

Silver Spring, MD, USA (January 31, 2012) – The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

Gleevec was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008 Gleevec received a subsequent accelerated approval for adjuvant use that is for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted. Regular approval for the metastatic GIST indication was also granted in 2008.

GIST is a rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which regulates body processes such as food digestion. More than half of GISTs start in the stomach.

“The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

The label is being updated to include clinical data from a large randomized clinical study comparing 12 to 36 months of Gleevec. Thirty-six months of Gleevec significantly prolonged overall survival and the time a patient lived without the disease recurring, compared to those receiving 12 months of Gleevec. At 60 months, 92 percent of patients who received 36 months of Gleevec were alive compared to 82 percent of patients who received 12 months of Gleevec.

Gleevec is a pill that should be taken with a meal and a glass of water.

The most common side effects observed in patients receiving Gleevec include swelling (edema), nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

Gleevec was first approved by FDA in May 2001 to treat patients with advanced Philadelphia chromosome positive chronic myeloid leukemia, a blood and bone marrow disease linked to a genetic abnormality.

Gleevec is marketed by Novartis Pharmaceuticals Corp. based in East Hanover, N.J.

For more information:

• FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer (2008)1
• FDA Office of Hematology and Oncology Products2
• FDA Approved Drugs: Questions and Answers3

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

U.S. Food and Drug Administration (FDA), 31.01.2012 (tB).