![](\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/07\/3ab1f57e3281e7d8b330d0e18f498ccbc2f451ed-200x275.jpg\"\/)
<\/p>\nPancreatic NETs | Image
Credit: \u00a9 Ashling Wahner
& MJH Life Sciences Using AI<\/p>\n
<\/p>\n
The European Commission (EC) has approved cabozantinib (Cabometyx) for adult patients with unresectable or metastatic, well-differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors (NETs) who have progressed following at least 1 prior systemic therapy other than somatostatin analogues.1<\/p>\n
This regulatory decision makes cabozantinib the first and only systemic therapy to be approved in the European Union for previously treated unresectable or metastatic NETs, regardless of tumor site, grade, or previous non\u2013somatostatin analogue\u2013based systemic therapy.<\/p>\n
Findings from the pivotal phase 3 CABINET trial (NCT03375320)\u200b\u200b supported the agent\u2019s approval.<\/p>\n
Final results presented at the 2024 ESMO Congress<\/strong><\/a> and subsequently published in the New England Journal of Medicine demonstrated a 77% and 62% reduction in the risk of disease progression or death with cabozantinib vs placebo in the pNET (n = 95) and epNET (n = 203) cohorts, respectively.1,2<\/p>\n In the epNET cohort, the median progression-free survival (PFS) was 8.4 months (95% CI, 7.6-12.7) vs 3.9 months (95% CI, 3.0-5.7) with cabozantinib and placebo, respectively (HR, 0.38; 95% CI, 0.25-0.59; P 2 The median PFS in the pNET cohort was 13.8 months (95% CI, 9.2-18.5) vs 4.4 months (95% CI, 3.0-5.9) with cabozantinib and placebo, respectively (HR, 0.23; 95% CI, 0.12-0.42; P <\/p>\n The confirmed objective response rate (ORR) with cabozantinib in the epNET and pNET cohorts, respectively, was 5% and 19%; comparably, the ORR was 0% in those treated with placebo. Notably, overall survival (OS) data were not mature at the time of the analysis and were potentially confounded by the trial\u2019s crossover design.1<\/p>\n \u201cThe complex nature of NETs and lack of innovation in recent years has resulted in significant physical and emotional strain for patients as their disease progresses,\u201d Sandra Silvestri, MD, PhD, executive vice president and chief medical officer of Ipsen, stated in a news release. \u201cWe are pleased that for the first time, this approval offers a unique, simplified, and efficacious treatment option upon progression, where few to no other options currently exist. We look forward to working with local health authorities to make cabozantinib available to even more patients, reinforcing our longstanding commitment to delivering transformational therapies in oncology.\u201d<\/p>\n