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The CABINET trial led the FDA to approve cabozantinib in March 2025 for adults and adolescents with previously treated advanced pancreatic and extra-pancreatic NETs.
Written by NECNZ team
In March 2025 the United States Food and Drug Administration approved cabozantinib (brand name Cabometyx) for adults and young people aged 12 and over with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumours (pNETs) and extra-pancreatic neuroendocrine tumours (epNETs). It is the first oral targeted therapy approved across both NET groups in this setting in several years, and the European Commission followed with its own approval in July 2025.
The decision was based on the CABINET trial (NCT03375320), an Alliance for Clinical Trials in Oncology study with two randomised cohorts – one for pancreatic NETs and one for extra-pancreatic NETs – in people whose disease had progressed on prior therapy. Both cohorts showed a clear improvement in progression-free survival with cabozantinib compared with placebo. In the pancreatic cohort, median progression-free survival was 13.8 months on cabozantinib versus 3.3 months on placebo (hazard ratio 0.22). In the extra-pancreatic cohort, median progression-free survival was 8.5 months versus 4.2 months (hazard ratio 0.40). Both differences were highly statistically significant.
Cabozantinib is a tyrosine kinase inhibitor – it blocks several signalling pathways, including VEGFR, MET and AXL, that tumours use to grow new blood vessels and resist treatment. Side effects in the trial were consistent with the known cabozantinib profile, with grade 3 or 4 events such as high blood pressure, diarrhoea and fatigue more common than in the placebo arm. The recommended dose for adults is 60 mg orally once daily, continued until disease progression or unacceptable toxicity.
What does this mean for people in Aotearoa? Cabozantinib is not currently funded by Pharmac for NETs, and a New Zealand approval and funding decision would be a separate process from the FDA's. Even so, the CABINET data are an important signal: there is now solid evidence for an oral option after first- or second-line treatment, including for extra-pancreatic NETs, where treatment choices have historically been more limited. If your specialist mentions cabozantinib in passing, this is the trial they are referring to. NECNZ will keep an eye on any local availability or trial access pathways.
Source 1: www.fda.gov
Source 2: www.cancernetwork.com
Source 3: ir.exelixis.com
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