EFN

U.S. Food and Drug Administration approval of Afinitor (everolimus) has been expanded to include people with progressive neuroendocrine tumors of the pancreas (PNET) that have spread to other parts of the body or cannot be removed by surgery, the agency said Friday.

“Data show Afinitor delays tumour growth and reduces risk of disease progression in patients with advanced neuroendocrine tumours (NET) of pancreatic origin,” the Swiss drugmaker said in a statement.

Neuroendocrine tumors, which can originate in the pancreas, lung and gastrointestinal tract, are a rare form of cancer. In most cases, the tumors are slow-growing and patients can live for many years. Estimates are that neuroendocrine tumors affect 2.5 out of every 100,000 people in the U.S. A study involving Afinitor showed it was able to stop tumor growth for about six months longer than patients on a placebo medicine.

“Patients with this cancer have few effective treatment options,” said Richard Pazdur, MD , director of the Office of Oncology Drug Products at the FDA, in a prepared statement. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

The drug is currently approved to treat patients with advanced renal cell carcinoma after they fail treatment with sunitinib (Sutent, Pfizer) or sorafenib (Nexavar, Bayer) and patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who cannot be treated by surgery, according to an FDA press release.