New Indication for Everolimus for Neuroendocrine Pancreatic Cancer

June 2011, Vol 2, No 3 - FDA Approvals, News & Updates


The FDA approved a new indication for everolimus (Afinitor; Novartis) for the treatment of metastasized or unresectable locally advanced progressive neuroendocrine tumors of pancreatic origin, a rare pancreatic cancer that progresses slowly.

Fewer than 1000 new cases are diagnosed annually in the United States.

“Patients with this cancer have few effective treatment options,” said Dr Pazdur. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

The recommended dosage for ever – olimus is 10 mg orally daily. Severe or intolerable adverse events may necessitate a temporary reduction of the dosage to 5 mg daily or a dose interruption.

The median PFS was 11 months with everolimus versus 4.6 months among those who received placebo. The most common grade 3 or 4 adverse events (≥5%) were stomatitis and diarrhea.

Everolimus is already indicated for the treatment of advanced renal-cell carcinoma that fails to respond to treatment with sunitinib (Sutent) or sorafenib (Nexavar) and for unresectable subependymal giant-cell astrocytoma associated with tuberous sclerosis. (May 5, 2011)