Exelixis宣布美国FDA接受卡博替尼用于晚期神经内分泌肿瘤患者的补充NDA

– The FDA assigned a Prescription Drug User Fee Act target action date of April 3, 2025 –

– Application is based on results from the phase 3 CABINET pivotal trial, in which cabozantinib provided a statistically significant and clinically meaningful improvement in progression-free survival versus placebo –

Exelixis, Inc. (NASDAQ:EXEL) today announced that its supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) has been accepted in the U.S. for: 1) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated pancreatic neuroendocrine tumors (pNET), and 2) the treatment of adults with previously treated, locally advanced/unresectable or metastatic, well- or moderately differentiated extra-pancreatic NET (epNET). The U.S. Food and Drug Administration (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.