Pfizer Inc.'s Cancer Therapy SUTENT(R) Receives FDA Approval

NEW YORK, Jan. 26 /PRNewswire/ -- The FDA has simultaneously approved SUTENT (sunitinib malate) capsules for two types of cancer. SUTENT has been approved to treat advanced renal cell carcinoma (RCC)*, also known as advanced kidney cancer. SUTENT has also been approved for malignant gastrointestinal stromal tumor (GIST), a type of soft-tissue cancer, after disease progression on or intolerance to imatinib mesylate.

SUTENT is an oral therapy belonging to a new class of multi-kinase inhibitors that attack cancer by inhibiting both tumor growth and blood supply. The FDA granted SUTENT priority review in October, 2005.

SUTENT is an oral, multi-kinase inhibitor. Receptor tyrosine kinases (RTKs) have been implicated in tumor growth, angiogenesis and the progression of cancer. By inhibiting these RTKs, SUTENT may impact tumor growth and angiogenesis.

In RCC and GIST trials, the most common adverse events included fatigue, diarrhea, nausea, mucositis/stomatitis, dyspepsia, altered taste, abdominal pain, anorexia, and skin discoloration.

Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.

Decrease in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.

Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. CBCs with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

* Note: Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma.

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SUTENT (sunitinib malate) capsules product shot, footage of doctors, patient and kidney cancer advocate, and directions to obtain full prescribing information.

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