FDA Announces New Indications for Stivarga

On February 25, 2013 the U.S. Food and Drug Administration announced approval of Stivarga (regorafenib) for a new indication, to treat patients with advanced gastrointestinal stromal tumors that cannot be surgically removed and no longer respond to other FDA-Approved treatments for this condition.

GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body’s digestive system. According to the National Cancer Institute, there are an estimated 3,300 to 6,000 new cases of GIST yearly in the United States. In GIST, cancerous cells form in the tissues of the gastrointestinal tract, and the disease occurs mainly in older adults.

Stivarga, a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or has spread to other parts of the body (metastatic) and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other FDA-approved drugs to treat GIST.

Stivarga was reviewed under the FDA’s priority review program, which provides an expedited six-month review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The drug was also granted orphan product designation because it is intended to treat a rare disease.

In the pivotal trials used to gain approval, patients who took Stivarga had a delay in tumor growth (progression-free survival) that was, on average, 3.9 months later than patients who were given placebo.

The most common side effects reported in patients treated with Stivarga were weakness and fatigue, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, loss of appetite, high blood pressure, mouth sores, infection, changes in voice volume or quality, pain, weight loss, stomach pain, rash, fever and nausea.

Serious side effects of Stivarga, which occurred in less than one percent of patients, were liver damage, severe bleeding, blistering and peeling of skin, very high blood pressures requiring emergency treatment, heart attacks and perforations (holes) in the intestines.

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