FDA to hold AdCom on Exelixis’ cabozantinib sBLA
After trading closed yesterday, Exelixis (Nasdaq: EXEL) revealed that the US Food and Drug Administration (FDA) has notified the company 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 NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025.
Developed by Exelixis, cabozantinib is licensed to French drugmaker Ipsen (Euronext: IPN) for territories outside the USA, Canada and Japan. Exelixis saw its shares dip 2.1% in early trading today.
The sNDA is based on the final results of the Phase III CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network, evaluating cabozantinib compared with placebo in advanced pNET and advanced epNET.
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