FRIDAY, Jan. 27 (HealthDay News) -- After a priority review, the U.S. Food and Drug Administration has approved Sutent (sunitinib malate) for the treatment of gastrointestinal stromal cancer after disease progression or intolerance to imatinib mesylate, and for advanced renal cell carcinoma.
The drug received accelerated approval for the treatment of advanced renal cell carcinoma, although the FDA notes that no randomized clinical trials have demonstrated clinical benefit such as increased survival or improvement of disease-related symptoms. Approval for the treatment of renal cancer was based on partial response rates and duration of responses.
"Today's approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, in an FDA statement. "New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives."
Sutent is manufactured by Pfizer.
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