ODAC backs Afinitor, Sutent sNDAs
FDA's Oncologic Drugs Advisory Committee voted in favor of sNDAs for two drugs to treat pancreatic neuroendocrine tumors: Afinitor everolimus from Novartis AG (NYSE:NVS; SIX:NOVN) and Sutent sunitinib from Pfizer Inc. (NYSE:PFE). The committee voted 10-0 that Afinitor had a favorable benefit-risk profile to treat advanced pancreatic neuroendocrine tumors. The sNDA is under Priority Review. Novartis already markets everolimus as Afinitor to treat advanced kidney cancer, as Certican to prevent transplant rejection, and as Zortress to prevent organ rejection of kidney transplants in adult patients at low to moderate immunologic risk. Afinitor is also approved to treat subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis (TS). ...