Sunitinib (Sutent; Pfizer) is the second new option for the treatment of metastasized or unresectable locally advanced progressive pancreatic neuroendocrine cancerous tumors. The “FDA believes it is important to provide cancer patients with as many treatment options as possible,” Dr Pazdur said. “The agency is committed to working with companies to bring innovative new therapies to the market and encourages companies to continue exploring additional uses for approved products.”
The recommended dose for sunitinib is 37.5 mg/day orally. A dose interruption or reduction to 25 mg daily may be necessary when adverse events are severe or intolerable.
The efficacy and safety of sunitinib were established in a single study of 171 patients with metastatic or unresectable locally advanced disease. The median PFS was 10.2 months with sunitinib compared with 5.4 months with placebo. The most common grade 3 or 4 adverse events (≥5%) were neutropenia, hypertension, palmar- plantar erythrodysesthesia syndrome, and leukopenia.
Sunitinib has previously been approved for the treatment of metastatic renal-cell carcinoma and gastrointestinal stromal tumor. (May 20, 2011)
