The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 8-2 yesterday that Pfizer’s sunitinib (SUTENT) provides a favorable benefit-risk profile in patients with unresectable pancreatic neuroendocrine tumors (pNETs).
The decision came hours after the committee unanimously voted to support a supplemental new drug application for Novartis’ everolimus (Afinitor). During the sunitinib ruling, panelists questioned Pfizer’s decision to stop the SUN 1111 study, saying that halting the trial made it difficult to accurately measure the drug’s efficacy.
A Pfizer press release stated that the trial was halted in February 2009, by an independent data monitoring committee in the interest of patient safety, based on the strong likelihood that the study would meet its primary endpoint if continued to completion.
In the final analysis, it was demonstrated that sunitinib more than doubled median progression-free survival, the primary endpoint, compared with placebo in 171 patients with progressive, well-differentiated pNET (N EnglJ Med
“Following today's discussion, we will work closely with the FDA to ensure that it has all of the information that it needs to finalize its review,” said Mace Rothenberg, MD, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. “If approved in the United States, sunitinib would be a major advancement in the treatment of patients with pNET, a disease for which there remains a significant unmet medical need.”
Advanced pNET is a rare, life-threatening form of cancer reported in 2 to 4 people per million annually worldwide. It accounts for approximately 22% to 28% of all neuroendocrine tumors. Prognosis is poor for patients with metastatic pNET, with a survival of only 1 to 3 years.
“The Caring for Carcinoid Foundation supports the ODAC recommendations and is encouraged that pancreatic neuroendocrine tumor patients are closer to having access to two new treatment options,” said Lauren Erb, executive director for the Foundation, who attended the hearing. “We applaud the committee for their vote to address the unmet need for safe and effective treatments.”
Chief Operating Officer of the Carcinoid Cancer Foundation,Grace Goldstein, who also spoke at the hearing on behalf of pNET patients, said, “The outcome of yesterday’s meeting, with votes in favor of Afinitor and SUTENT, is a milestone for pNET patients. This is a rare disease with very few treatment options. When patients call our foundation and ask, ‘Where can I find a doctor who specializes in my cancer, what medications can I take, what options are available to me?’ I will be able to tell them about two new treatments. I believe these drugs will add both quality of life and length of life for pNET patients and what could give greater hope to a patient facing the challenges of a rare cancer. It is truly life-affirming.”