The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for cabozantinib Ipsen in adults with unresectable or metastatic neuroendocrine tumours (NETs) whose disease has progressed after at least one prior systemic therapy. The treatment, developed by Ipsen, is the first licensed systemic option in the UK for these patients.

This approval makes cabozantinib the first and only systemic therapy licensed in the UK for previously treated NETs, offering a new treatment option for patients with a rare and complex cancer.

The decision was based on the pivotal Phase 3 CABINET trial, which showed significant reductions in the risk of disease progression or death: 77% in pancreatic NETs and 62% in extra-pancreatic NETs versus placebo. Median progression-free survival (PFS) reached 13.8 months for cabozantinib in pancreatic NETs and 8.4 months in extra-pancreatic NETs, compared with 4.4 and 3.9 months for placebo, respectively. Health-related quality of life was maintained, and the safety profile aligned with previous experience.

“This UK marketing authorisation marks a critical milestone in making a licensed and efficacious treatment option available to patients upon progression,” said Dr Ian Gray, UK & Ireland interim medical director at Ipsen.