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Lauren and Nick.
Dave, Suzi, Lauren - Philadelphia, PA
FDA Advisory Panel Recommends Two Drugs for Patients with Pancreatic Neurendocrine Tumors
On Tuesday April 12, I had the honor of speaking on behalf of neuroendocrine cancer patients at an ODAC (Oncologic Drug Advisory Committee, an FDA advisory committee) hearing regarding two potential treatment options for pancreatic neuroendocrine tumor patients:
1) Afinitor (everolimus) tablets for treatment of patients with advanced neuroendocrine tumors of pancreatic origin;
2) Sutent (sunitinib malate) capsules for treatment of unresectable pancreatic neuroendocrine tumors.
The committee discussed everolimus in the morning and sunitinb in the afternoon. It was very informative to hear the discussion between the FDA, the trial sponsors (Novartis and Pfizer, respectively), and the sponsors' expert witnesses, which included several neuroendocrine tumor clinicians.
At the onset of the hearing I was reminded of how long it takes to develop new treatments for patients. For Sutent, there was evidence of effectiveness in neuroendocrine tumor patients in a 2005 phase II trial. It has taken six years to advance this finding from phase II to ODAC review. For more information regarding the FDA’s drug review process please see this section from FDA’s website. As I stated at the hearing, the Caring for Carcinoid Foundation encourages the FDA and pharmaceutical companies to work to develop and evaluate all potential promising therapies for neuroendocrine cancer patients as soon as possible. This includes peptide receptor radiotherapy, everolimus and sunitinib.
CFCF-funded research was cited in the morning as evidence of the scientific rationale for everolimus to treat pancreatic neuroendocrine tumors. Dr. James Yao described the CFCF-funded genome study that identified somatic mutations in the mTOR pathway among pancreatic neuroendocrine tumor patients. Click here for more information on this finding.
During both sessions, I had the opportunity to present the feedback I received from patients on both everolimus and sunitinib. Please view my complete remarks here and here. At the conclusion of both the morning and afternoon sessions, the committee voted on the risk-to- benefit profile of everolimus and sunitinib, respectively. I was proud to hear my points echoed in discussion during the votes - including the need identify predictive biomarkers that correlate with patient response to therapy.
The committee voted in favor of both everolimus and sunitinib for pancreatic neuroendocrine tumor patients. In both votes the committee recognized the significant, urgent, unmet needs of neuroendocrine tumor patients.
The committee also accepted progression-free survival as an acceptable endpoint for clinical trials among pancreatic neuroendocrine tumor patients.
The Caring for Carcinoid Foundation supports the ODAC recommendations and is encouraged that pancreatic neuroendocrine tumor patients are closer to having two new treatment options. We applaud the committee for their vote to address the unmet need for safe and effective treatments. Furthermore, we underscore the importance for patients considering these or other potential treatments to consult with a physician well-versed in treating neuroendocrine tumor patients. Please consult or Doctor Database or call us at 617-948-2514 for more information on finding a doctor. Experienced clinicians are necessary to understand the best timing and duration of therapy with these and other treatments. We encourage you to continue educating yourself and others about the latest in neuroendocrine cancer treatments. Keep checking our website for the latest news.