CHMP recommends approval for Cabometyx as first line treatment for advanced renal cell carcinoma.- Ipsen.

Ipsen announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx (cabozantinib) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma (aRCC). The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

The positive CHMP opinion follows EMA approval in 2016 for the treatment of aRCC after prior VEGF-targeted therapy. The CHMP positive opinion was based on the CABOSUN trial, which demonstrated that cabozantinib prolongs progression-free survival (PFS) in treatment-naive aRCC patients with intermediate- or poor-risk. Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-na�ve aRCC patients with intermediate- or poor-risk.

Comment: With the incidence predicted to rise 22% by 2020, renal cell carcinoma (RCC) threatens to become one of the fastest growing cancers in the world. Targeted therapies including tyrosine kinase inhibitors (TKIs) of the VEGF receptor (VEGFR) introduced a decade ago, significantly transformed the treatment landscape of aRCC.