Ipsen has been given marketing authorisation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for cabozantinib, to be used for patients with previously treated, unresectable or metastatic neuroendocrine tumours (NETs).
This is the first time the agency has authorised a treatment of this type, which can be used irrespective of tumour site or prior systemic therapy.
NETS affect an estimated 35 out of every 100,000 people in England and often require multiple lines of therapy as the disease progresses. Effective treatment options are limited, with factors such as the primary tumour site complicating the determination of optimal treatment sequencing.
The authorisation is based on positive data from the phase 3 CABINET trial, which assessed cabozantinib versus placebo in patients with advanced pancreatic NETs (pNETs) and extra-pancreatic NETs (epNETs). In both cohorts, cabozantinib demonstrated a statistically significant reduction in the risk of disease progression and death, with median progression-free survival improved compared with placebo.
“This UK marketing authorisation marks a critical milestone in making a licensed and efficacious treatment option available to patients upon progression. We are actively engaging with NICE to ensure that individuals living with this often overlooked form of cancer in the UK have timely access to this approved therapeutic option,” said Ian Gray, UK & Ireland interim medical director at Ipsen.
Cabozantinib was also granted marketing authorisation in Europe earlier this year by the European Medicines Agency (EMA). The recommendation followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June. A final review by NICE is expected later this year.