Exelixis announces cabozantinib sNDA accepted by FDA

Exelixis announced that its supplemental new drug application, or sNDA, for cabozantinib has been accepted in the U.S. for the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors, and the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated extra-pancreatic NET, or epNET. The FDA also granted orphan drug designation to cabozantinib for the treatment of pNET. The FDA assigned a standard review with a Prescription Drug User Fee Act target action date of April 3, 2025.