Exelixis: FDA To Review Supplemental New Drug Application For Cabozantinib

(RTTNews) - Exelixis, Inc. (EXEL) announced that its supplemental New Drug Application 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. The FDA assigned a standard review with a Prescription Drug User Fee Act target action date of April 3, 2025.

The company said the sNDA is based on the final results of the phase 3 CABINET pivotal trial evaluating cabozantinib compared with placebo in two cohorts of patients with previously treated NET: advanced pNET and advanced epNET.

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