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FDA has approved Sutent in GIST and advanced kidney cancer


The FDA ( Food and Drug Administration ) announced approval of Sutent ( Sunitinib ), a new targeted anti-cancer treatment for patients with gastrointestinal stromal tumors ( GIST ), a rare stomach cancer, and advanced kidney cancer.

Sutent is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.

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

Sutent was approved for the treatment of patients with gastrointestinal stromal tumors (GIST ) whose disease has progressed or who are unable to tolerate treatment with Imatinib ( Gleevec/Glivec ) , the current treatment for GIST patients.

While studying the treatment in patients, researchers conducted an early (interim) analysis of data that showed Sutent delayed the time it takes for tumors or new lesions to grow in patients with this rare type of stomach cancer. Specifically, the median time-to-tumor progression ( TTP ) for patients treated with Sutent was 27 weeks compared to 6 weeks for patients who were not treated.

FDA also granted accelerated approval for Sutent in the treatment of 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 the tumors, this approval was based on Sutent's ability to reduce the size of the tumors in patients. An overall response rate ranging from 26-37 percent was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy.

Source: FDA, 2006


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