Viewpoints / Position Papers
Novartis drug approved to treat pancreatic neuroendocrine tumors
The U.S. Food and Drug Administration (FDA) announced on Friday, May 6th, that the Novartis drug Afinitor® (everolimus) has been approved for the treatment of advanced pancreatic neuroendocrine tumors. Neuroendocrine tumors make up less than five percent of all pancreatic cancer diagnoses and are generally slower growing and less aggressive than the more common form of pancreatic cancer, pancreatic adenocarcinoma. For more information about pancreatic neuroendocrine tumors, please click here.
Afinitor® underwent rigorous clinical trials to determine the safety and effectiveness of the drug in this specific cancer type. It was previously approved to treat other cancer types, but needed to prove effective in patients with pancreatic neuroendocrine tumors. To this point, treatment options for pancreatic neuroendocrine tumors have not been well-established. Patients have historically been treated with surgery, chemotherapies, and/or radiation. In contrast to these treatment modalities, Afinitor® is a targeted therapy designed to attack specific proteins that are necessary for the growth of cancer cells.
The clinical trial of Afinitor® in pancreatic neuroendocrine cancer patients was multinational. The progression-free survival of patients treated with Afinitor® was significantly longer than those treated with best supportive care. The most common side effects on this drug were inflammation in the mouth, rash, diarrhea, fatigue, and infections (mostly upper respiratory).
The Oncologic Drugs Advisory Committee recommended Afinitor® for FDA approval for pancreatic neuroendocrine tumors in mid-April, 2011. Now that the FDA has approved the drug, it will be available for patients who are diagnosed with advanced pancreatic neuroendocrine tumors (but not for patients with pancreatic adenocarcinoma, the most common form of pancreatic cancer).
The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. For more information about ongoing clinical trials or other questions about pancreatic cancer diagnosis and treatment, please contact a Pancreatic Cancer Action Network Patient and Liaison Services (PALS) Associate toll-free at 877-272-6226 or email firstname.lastname@example.org. PALS Associates are available M-F 7am-5pm Pacific Time.