Ipsen has announced that its Exelixis-partnered Cabometyx (cabozantinib) has been recommended by the European Medicines Agency’s human medicines committee to treat advanced neuroendocrine tumours (NETs).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be authorised to treat unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic NETs in adults who have progressed following at least one prior systemic therapy other than somatostatin analogues.
The number of people newly diagnosed with NETs, tumours that arise from the neuroendocrine cells found throughout the body, is believed to be rising. Most NETs develop slowly over a number of years and patients often need multiple lines of therapy as the disease progresses.
Cabometyx is designed to block the action of multiple receptor tyrosine kinases, which can be found in certain receptors in cancer cells and help to send growth signals. The drug is already approved in the EU to treat certain cases of renal cell carcinoma, thyroid carcinoma and hepatocellular carcinoma.
The CHMP’s positive opinion was based on results from the phase 3 CABINET trial, in which Cabometyx demonstrated continued improvement in the primary endpoint of progression-free survival (PFS).
Among patients with pancreatic NETs, median PFS was 13.8 months for Cabometyx versus 4.4 months for placebo after a median follow-up of 13.8 months. For those with extra-pancreatic NETs, median PFS was 8.4 months and 3.9 months for Cabometyx and placebo, respectively, at a median follow-up of 10.2 months.
The European Commission (EC) will now review the CHMP’s recommendation as it makes a final decision on Cabometyx in this indication.
Christelle Huguet, executive vice president and head of research and development at Ipsen, said: “The significant efficacy data demonstrated in the CABINET phase 3 trial has provided the opportunity to reframe conversations on care approaches for people living with advanced pancreatic and extra-pancreatic NETs.
“[The] positive CHMP opinion confirms the potential to translate this data into meaningful benefits for patients and we look forward to receiving the final decision from the EC.”
Exelixis holds exclusive rights to develop and commercialise Cabometyx in the US, and has granted Ipsen exclusive rights to the drug outside of the US and Japan, and exclusive rights to Takeda in Japan.