New targeted therapy for rare stomach, kidney cancers

FDA Consumer, May-June, 2006

The FDA has approved Sutent (sunitinib), a new targeted anti-cancer medicine to treat patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer.

The approval of Sutent is a major step forward in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer, says Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research. "New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives."

The drug's approval in January marks the first time the agency has approved a new oncology product for two indications simultaneously.

According to the American Cancer Society, about 5,000 cases of GIST and 32,000 new cases of advanced kidney cancer are diagnosed each year.

Sutent was approved for patients with GIST whose disease has progressed or who are unable to tolerate treatment with Gleevec, the current treatment for GIST. Early data showed that Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare stomach cancer.

The FDA also granted accelerated approval for Sutent in treating patients with advanced renal cell carcinoma (RCC). In contrast to the approval for GIST, which was based on the drug's ability to delay the growth of tumors, RCC approval was based on the drug's ability to reduce the size of tumors in patients.

Some common side effects reported with Sutent are diarrhea, skin discoloration, mouth irritation, weakness, and altered taste.

Sutent is distributed by Pfizer Labs of New York City.