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FDA Approves Drug to Treat Gastrointestinal Stromal Tumors

Feb 27, 2013 02:36 AM EST

A new drug Stivarga has won the approval of the U.S. Food and Drug Administration to cure patients who are victims of advanced gastrointestinal stroma tumors (GIST) that cannot be removed surgically and have failed to respond to other FDA-approved treatments.

"Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, was quoted as saying in a press statement. "It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective."

According to the National Cancer Institute, nearly 3,300 to 6,000 new cases of GIST occur yearly in the United States, with older adults often being the victims. GIST is a phase where cancerous cells form in the tissues of the gastrointestinal tract, which is a part of the digestive system.

The new drug Stivarga is a mutli-kinase inhibitor that blocks several enzymes that promote cancer growth. It is being granted the orphan product designation as it is intended to treat a rare disease.

In order to check the safety and effectiveness of the newly-approved drug, a clinical study was conducted on 199 patients who were victims of GIST. The tumor could be surgically removed and advanced after treating with Gleevec or Sutent, two other FDA-approved drugs to cure GIST.

The patients were either given Stivarga or a placebo until either the cancer advanced or the side effects became unacceptable. It was seen that those who took Stivarga had a delay in tumor growth, nearly 3.9 months later than those who received the placebo.

The drug carries certain side-effects such as weakness, fatigue, hand and foot syndrome, loss of appetite, diarrhea, high blood pressure, weight loss, fever, nausea, mouth sores and rash.

Serious damage occurring in less than 1 percent included live damage, severe bleeding, peeling of skin, very high blood pressures requiring immediate treatment, heart attacks, and perforations in the intestines.

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