Cabometyx® is the first and only systemic therapy to be approved in the European Union for previously treated unresectable or metastatic neuroendocrine tumors, regardless of tumor site, grade or previous non-somatostatin analogue-based systemic therapy1,2Approval based on pivotal CABINET Phase III trial which demonstrated a 77% and 62% reduction in the risk of disease progression or death versus placebo in advanced pancreatic and extra-pancreatic neuroendocrine tumors, respectively3,4 PARIS, FRANCE, 24 July ...

Core Viewpoint - Ipsen has received a positive opinion from the CHMP of the EMA for Cabometyx® (cabozantinib) for adult patients with unresectable or metastatic neuroendocrine tumors, based on the CABINET Phase III trial results, with a final decision expected soon [1][6]. Company Summary - Ipsen is a global biopharmaceutical company focused on oncology, rare diseases, and neuroscience, with nearly 100 years of development experience [11]. - The company has exclusive rights for the commercialization and clinical development of Cabometyx outside the U.S. and Japan, while Exelixis retains rights in the U.S. [8]. Industry Summary - The incidence of neuroendocrine tumors (NETs) is increasing, with a higher prevalence than pancreatic or bladder cancer, and treatment options are often limited upon disease progression [2]. - The CABINET Phase III trial demonstrated significant efficacy for Cabometyx, showing median progression-free survival (PFS) of 13.8 months for pNET patients compared to 4.4 months for placebo [7]. - For advanced gastrointestinal and lung NETs, the five-year survival rates are 68% and 55%, respectively, while advanced pNET has a poor prognosis with a five-year survival rate of only 23% [3].