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FDA-Approved Drugs

Sutent (sunitinib)

FDA approved January 2006

This drug is approved for patients with gastrointestinal stromal tumors (GIST), a rare stomach cancer, and advanced kidney cancer.

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 Gleevec, 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.

The most commonly reported Sutent-related side effects included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste. Patients treated with Sutent also experienced, fatigue, high blood pressure, bleeding, swelling, and taste disturbance. Hypothyroidism was also observed.

Mitozytrex (mitomycin C)

FDA approved prior to 1984

Mitomycin interferes with the growth of rapidly dividing cells, like cancer cells, and eventually causes these cells to die. Mitomycin may be used alone or with other chemotherapy agents or radiation therapy.

Gleevec (imatinib mesylate)

FDA approved February 2002

This drug is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase. It targets specific proteins within distinct cancer cells and stops the cancer cells from growing.

It is used to treat adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML), and gastrointestinal stromal tumors (GIST), a rare stomach cancer.

The most commonly reported Gleevec-related side effects included fluid retention, nausea, muscle cramps, bleeding, rash, fatigue, diarrhea, headache, joint pain, and belly pain.



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