FDA OKs Afinitor to Treat Pancreatic Cancer

May 6, 2011 -- The FDA has approved the drug Afinitor (everolimus) to treat a rare type of pancreatic cancer.

The Novartis-made drug has been approved to treat patients with progressive neuroendocrine tumors located in the pancreas that cannot be surgically removed or which have spread to other parts of the body.

Neuroendocrine tumors found in the pancreas are slow-growing and rare. The FDA says fewer than 1,000 new cases are reported in the U.S. each year.

“Patients with this cancer have few effective treatment options,” says Richard Pazdur, MD, of the FDA’s Center for Drug Evaluation and Research, in a news release. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

Safe and Effective

The safety and effectiveness of the drug was established in a clinical trial in 410 patients with metastatic, late-stage cancer or cancer that couldn’t be removed with surgery, the FDA says.

Patients in the study were selected to receive either Afinitor or a placebo.

The median length of time patients lived who were taking Afinitor without the cancer spreading or worsening was 11 months, compared with 4.6 months for those on placebo. Patients on placebo were allowed to take Afinitor if their disease worsened.

The FDA says patients treated with Afinitor for neuroendocrine pancreatic tumors might have side effects including inflammation of the mouth, rash, diarrhea, fatigue, swelling, stomach pain, nausea, fever, and headache.

Afinitor for Kidney and Brain Cancer

Afinitor also is approved to treat patients with kidney cancer after they fail with the drugs Sutent or Nexavar.  It also is approved for use with patients with a type of brain cancer associated with tuberous sclerosis, a disease that causes tumors in various parts of the body that cannot be treated surgically.

Afinitor has another trade name, Zortress, and is approved to treat certain adult patients to prevent organ rejection after a kidney transplant. It is marketed by Novartis, a major pharmaceutical company based in East Hanover, N.J.

The cancer for which Afinitor was approved is the same type of pancreatic cancer that Steve Jobs, co-founder of Apple, was diagnosed with in 2004.