Ipsen Pharma SAS

FDA Foregoes Advisory Committee for Cabozantinib's Neuroendocrine Tumor Application

4 months ago

• The FDA has canceled the Oncologic Drugs Advisory Committee meeting for Exelixis' cabozantinib sNDA, streamlining the review process. • The sNDA seeks approval for cabozantinib to treat advanced pancreatic and extra-pancreatic neuroendocrine tumors in previously treated adults. • The FDA's decision is based on Phase III CABINET trial results, which showed significant progression-free survival improvements with cabozantinib. • The Prescription Drug User Fee Act (PDUFA) target action date for the FDA's decision on cabozantinib remains April 3, 2025.

Cabozantinib Shows Promise in Gastrointestinal Neuroendocrine Tumors: Phase 3 CABINET Subgroup Analysis

6 months ago

• Cabozantinib significantly improved progression-free survival (PFS) compared to placebo in patients with advanced gastrointestinal neuroendocrine tumors (GI NETs). • The subgroup analysis of the Phase 3 CABINET study revealed a 50% reduction in the risk of disease progression or death with cabozantinib. • Median PFS was 8.5 months with cabozantinib versus 5.6 months with placebo, demonstrating a clinically meaningful benefit. • Exelixis is working with the FDA on the supplemental New Drug Application (sNDA) for cabozantinib in advanced neuroendocrine tumors, with a decision expected April 3, 2025.