The European Commission has approved cabozantinib (Cabometyx) for the first-line treatment of advanced renal cell carcinoma (RCC).
The approval is based on data from the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in people with untreated advanced RCC at intermediate or poor-risk of the cancer spreading.
Cabozantinib, a tyrosine kinase inhibitor, is the first drug to demonstrate superior clinical efficacy over sunitinib in advanced RCC. Median PFS with cabozantinib was 8.6 months versus 5.3 months for sunitinib, which is a 52% reduction in the hazard for progression or death.
Harout Semerjian, executive vice president and chief commercial officer at Ipsen, said: “Today’s EC approval is 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.
“Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”