EC approves Cabometyx tablets to treat advanced RCC following VEGF-targeted therapy

US biopharmaceutical firm Exelixis discovered and developed Cabometyx, which is claimed to be the first and only therapy approved in the European Union to demonstrate enhanced overall survival, progression-free survival and objective response rate in a phase 3 trial of patients with advanced kidney cancer.

Earlier this year, Exelixis signed a exclusive licensing agreement with French pharmaceutical firm Ipsen to commercialize and develop Cabometyx in regions outside the US, Canada and Japan.

The EC approval triggers a $60m milestone payment to Exelixis under the deal. The US firm is also eligible to receive $50m after the filing and approval of cabozantinib in Europe for advanced hepatocellular carcinoma, and further regulatory milestones for potential other indications.

Ipsen CEO David Meek said: “The approval of Cabometyx (cabozantinib) in Europe provides a breakthrough treatment to physicians and their patients suffering from renal cancer who failed on initial therapy.

“This oral drug has the potential to become a new standard of care in the second line setting of advanced renal cell carcinoma as it prolongs survival, slows disease progression, and shrinks tumors, with a clinically-acceptable safety and tolerability profile.”

Cabometyx is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

The drug inhibits the activity of tyrosine kinases including vascular endothelial growth factor (VEGF) receptors, MET, AXL and RET. In preclinical models, Cabometyx has been demonstarted to inhibit the activity of these receptors.

Earlier this year, the US Food and Drug Administration approved Cabometyx to treat patients with advanced RCC who have received prior anti-angiogenic therapy.

Earlier this month, the EC approved Cabometyx for the treatment of advanced renal cell carcinoma in adults who have received prior VEGF-targeted therapy in the European Union, Norway and Iceland.

Image: High magnification micrograph of a clear cell renal cell carcinoma. Photo: courtesy of Nephron.