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Thursday, January 9, 2025

Exelixis says no FDA AdCom for Cabometyx label expansion

 Exelixis, Inc. (Nasdaq: EXEL) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting. The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.

https://www.biospace.com/press-releases/exelixis-provides-update-on-oncologic-drugs-advisory-committee-meeting-for-cabozantinib-cabometyx-for-the-treatment-of-patients-with-previously-treated-advanced-neuroendocrine-tumors

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