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FDA Approves Stivarga (Regorafenib) for GIST

Drug is already indicated for colorectal cancer (Feb. 25)

The FDA has expanded the approved use of Stivarga (regorafenib, Bayer) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and that no longer respond to other FDA-approved treatments for this disease.

According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur each year in the U.S., most often in older adults.

Stivarga (regorafenib), a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With the new FDA approval, the drug may now be used in patients whose GIST malignancies cannot be removed by surgery or have metastasized to other parts of the body and are no longer responding to Gleevec (imatinib, Novartis) or Sutent (sunitinib, Pfizer) — two other FDA-approved drugs for the treatment of GIST.

The safety and effectiveness of Stivarga (regorafenib) for this use were evaluated in a clinical study of 199 patients with GIST that could not be surgically removed and that had progressed after treatment with Gleevec or Sutent. The patients were randomly assigned to receive either Stivarga or placebo. Treatment continued until either the cancer progressed or the side effects became unacceptable. All of the patients also received optimal supportive care, which included treatments to help manage the side effects and symptoms of cancer.

The patients treated with Stivarga showed delayed tumor growth (progression-free survival), which occurred, on average, 3.9 months later than that in patients who were given placebo. The placebo-treated patients had the opportunity to switch to Stivarga when their cancer progressed.

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

Serious side effects, which occurred in less than 1% of patients, included liver damage; severe bleeding; blistering and peeling of the skin; severe hypertension requiring emergency treatment; heart attacks; and intestinal perforations.

Stivarga (regorafenib) was approved in September 2012 for the treatment of colorectal cancer.

Source: FDA; February 25, 2013.

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