The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency's (EMA) scientific committee, has provided Ipsen (EPA: IPN) with a positive opinion for Cabometyx (cabozantinib) 20, 40, 60mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (aRCC), the company disclosed on Friday.

The European Commission (EC), which has the authority to approve medicines for the European Union, will now review the positive CHMP opinion.

This positive opinion follows approval from the EMA in 2016 for the treatment of aRCC to patients who have previously had VEGF-targeted therapy.

The CHMP's positive opinion was based on the randomised, open-label, active-controlled Phase II CABOSUN trial, which demonstrated that cabozantinib prolongs progression-free survival in treatment-naïve aRCC patients with intermediate- or poor-risk. It is the first and only monotherapy to demonstrate superior clinical efficiency over sunitinib in treatment-naïve patients with intermediate- or poor-risk.

Detailed recommendations will be described in the Summary of Product Characteristics (SmPC), which is to be made available once the EC has issued its decision.