Exelixis Announces U.S. Food and Drug Administration (FDA) Accepted the Supplemental New Drug Application for Cabozantinib for Patients with Advanced Neuroendocrine Tumors
This application acceptance moves Cabozantinib (CABOMETYX®) an oral, targeted medication one step closer to adding another treatment tool to the toolbox for previously treated, metastatic, well or moderately differentiated neuroendocrine tumors for pancreatic NET and extra-pancreatic NETs (meaning NETs outside of the pancreas including gastrointestinal and lung).
sNDA is an application to allow a company to make changes to a product that already has an approved new drug application (NDA). Exelixis will continue to work with the FDA as they review the application.
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.
ALAMEDA, Calif. — August 6, 2024 – 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.
Read the Exelixis press release.
Watch the LACNETS interview with Dr. Jennifer Chan explaining the CABINET trial data.
This blog is for educational purposes only and does not constitute medical advice. It does not provide a medical professional’s opinion or advice, nor is it an endorsement of particular treatments. You are advised to seek appropriate licensed medical/professional help and discuss your individual care and treatment plan with your medical team.
The content in this blogpost is the opinion of the author and the information is neither provided by nor endorsed by pharmaceutical companies.
Comments