Ipsen has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for cabozantinib for adult patients with unresectable or metastatic, well differentiated pancreatic NETs (pNETs) and extra-pancreatic NETs (epNETs), who have progressed following at least one prior systemic therapy other than SSAs.
The MHRA decision was based on data from the Phase III CABINET trial which investigated cabozantinib versus placebo in people living with advanced pNETs and epNETs, whose disease had progressed after prior systemic therapy, excluding non-somatostatin analogue-based SSA-based systemic therapies.
Trial results, as presented at the 2024 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine, demonstrated a 77 percent and 62 percent reduction in the risk of disease progression or death versus placebo in advanced pNETs and epNETs, respectively.
Cabozantinib has been submitted for review by NICE, with a decision expected later in 2025.
The drug was granted marketing authorisation by the European Medicines Agency (EMA) for advanced neuroendocrine tumours (NETS) in July following a positive opinion from the Committee for Medicinal Products for Human Use in June.
Most forms of NETs develop slowly, can originate in various parts of the body and require multiple lines of therapy as the disease progresses.
In England, NETs affects approximately 35 per 100,000 people, and the number of people newly-diagnosed with the disease is on the rise globally, and has a higher estimated prevalence than pancreatic or bladder cancer.
