The European Commission has approved Ipsen/Exelixis’ Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma (RCC).
The approval rides on the back of data from the CABOSUN trial, which showed that Cabometyx (cabozantinib) prolongs progression-free survival (PFS) in treatment-naive advanced RCC patients with intermediate- or poor-risk disease.
According to the findings, patients given Cabonetyx had a median PFS of 8.6 months versus 5.3 months for those treated initially with sunitinib (Pfizer’s Sutent), marking a 52 percent reduction in the hazard for progression or death.
The drug was first cleared by European regulators in the kidney cancer setting for use in patients with advanced disease following prior vascular endothelial growth factor (VEGF)-targeted therapy in September 2016, which was followed by an endorsement by the National Institute for Health and Care Excellence for its use on the NHS in July last year.
The expanded approval marks “a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Ipsen’s chief commercial officer.
The drug is also approved in Europe for under the brand-name Cometriq for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer.
Exelixis and Ipsen signed an exclusive licensing agreement in February 2016 for the commercialisation and further development of cabozantinib indications outside of the US and Canada.