Exelixis Reports the US FDA’s sNDA Acceptance of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors
Shots:
- The US FDA has accepted the sNDA of Cabometyx in treatment-experienced adults with locally advanced, unresectable or metastatic, well or moderately differentiated pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET), with the decision anticipated on Apr 3, 2025
- The sNDA was based on P-III (CABINET) study assessing Cabometyx vs PBO among 290 US patients during interim analysis in ratio 2:1 across 2 cohorts (pNET: n=93; epNET: n=197)
- CABINET was stopped early due to a significantly improved PFS at interim analysis, confirmed by both local and central reviews. Initial data was highlighted at ESMO 2023 & final results will be featured at ESMO 2024
Click here to read the full press release
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