The FDA approved sunitinib (Sutent) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have metastasized.
This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved everolimus (Afinitor) for this indication.
The safety and effectiveness of sunitinib was established in a single study of 171 patients with metastatic or locally advanced disease who received the drug or a placebo. The study was designed to measure progression-free survival. Results from the study demonstrate that sunitinib improved progression-free survival to 10.2 months compared to 5.4 months for patients who received placebo.
In patients treated with sunitinib for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, hypertension, asthenia, abdominal pain, changes in hair color, stomatitis, and neutropenia.
Sunitinib is also FDA-approved to treat patients with metastatic renal cell carcinoma and those with gastrointestinal stromal tumor. The drug is marketed by Pfizer. ■