FDA expands approval of Bayer’s cancer drug
The US FDA approval of Bayer’s Stivarga has been expanded so as to treat rare disease patients with advanced gastrointestinal stromal tumours (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease, such as Gleevec and (imatinib) and Sutent (sunitinib).
GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body’s digestive system. Up to an estimated 6000 new cases of GIST occur yearly in the United States, most often in older adults, according to the National Cancer Institute.
“Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors. It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective.”
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA expanded the approval of Stivarga through its priority review program and granted the drug orphan product designation because it is intended to treat a rare disease.
Stivarga was first approved for use in the United States back in September 2012 to treat colorectal cancer.
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