Sutent (sunitinib malate) and Afinitor (everolimus) were recommended for approval for the treatment of unresectable pancreatic neuroendocrine tumors, a rare type of pancreatic cancer - by the FDA Oncologic Drugs Advisory Committee. Patients with advanced pancreatic neuroendocrine tumors (pNET) have limited treatment options; no new drug has been approved in three decades. Unresectable means that it cannot be removed by surgery.
Pancreatic neuroendocrine tumors affect approximately 0.32 in every 100,000 people, a very rare type of cancer. Unlike other pancreatic cancers, which result in death within a few months, pNET generally grows more slowly. Approximately 95% of all pancreatic cancers are pancreatic adenocarcinomas.
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit, said:
"We are encouraged by the panel's favorable review of sunitinib for the treatment of unresectable pancreatic NET. 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. If approved in the United States, sunitinib would be a major advancement in the treatment of patients with pancreatic NET, a disease for which there remains a significant unmet medical need."
Although the FDA Advisory Committee's recommendations are not binding, the Agency tends to go along with what their members advise. Earlier on in the day the Committee recommended that another drug, Afinitor (everolimus) also be approved for the same type of cancer.
The Committee appeared to be more impressed with Novartis' everolimus (Afinitor), which received a unanimously favorable vote, compared to 8-2 in favor of Pfizer's sunitibib (Sutent), a tyrosine kinase inhibitor.
Everolimus, which already was approved for kidney cancer treatment by the FDA on March 30, 2009, will probably exceed sales of $1.3 billion in 2015, experts estimate. Sunitinib is also an existing kidney-cancer drug - it was approved for the treatment of renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumor (GIST) on January 26, 2006. Everolimus is currently used as an immunosuppressant to prevent the body from rejecting transplanted organs.
The Data Monitoring Committee for the SUN 111 trial (for Sutent) recommended the halting of randomization for the study in interest of patient safety and also on data indicating a high probability the study would meet its primary endpoint - progression-free survival - if it were to carry on to the end date of the study. A final analysis showed that Sutent more than doubled progression-free survival.
Written by Christian Nordqvist