The European Commission approves Cabometyx combined with Opdivo for first-line treatment of patients with advanced renal cell carcinoma

CompileKe Ke

On March 31, Ipsen announced that the European Commission (EC) has approved Cabometyx (cabozantinib) in combination with Bristol-Myers Squibb (BMS) Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC).

The EC’s approval is based on the results of the pivotal Phase III CheckMate-9ER trial, which was presented at the 2020 European Society of Medical Oncology (ESMO) Virtual Conference Chairperson’s Symposium and published in New England Medicine on March 3, 2021 Magazine (NEJM).

In this trial, all efficacy endpoints of the combination of Cabometyx and Opdivo were significantly improved.

In addition, Cabometyx combined with Opdivo showed a higher objective response rate (ORR).

Other data from the CheckMate-9ER trial was also published at the American Society of Clinical Oncology 2021 Urogenital Cancer Symposium (ASCO-GU) in February this year.

The approval allows the sale of Cabometyx and Opdivo products in all 27 EU member states, Norway, Liechtenstein and Iceland.

Reference source: European Commission Approves Cabometyx® in Combination With Opdivo® as a First-Line Treatment for Patients Living With Advanced Renal Cell Carcinoma