Press Announcements > FDA approves Sutent for rare type of pancreatic cancer

The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

This is the second new approval by the FDA to treat patients with this disease; on May 5, the agency approved Afinitor (everolimus).

The safety and effectiveness of Sutent was established in a single study of 171 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease who received Sutent or a placebo. The study was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

Results from the study demonstrate that Sutent provided benefit to patients by prolonging the median length of time they lived without the cancer spreading or worsening to 10.2 months compared to 5.4 months for patients who received placebo.

In patients treated with Sutent for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), abdominal pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).
Sutent is also FDA-approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with GIST (gastrointestinal stromal tumor), a rare cancer of the stomach, bowel, or esophagus.

For more information, please visit: Sutent
Press Announcements > FDA approves Sutent for rare type of pancreatic cancer