"Immunity + Targeting" combination Opdivo + Cabometyx is about to be approved in the EU

Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting the approval of the anti-PD-1 therapy Opdivo (common name: nivolumab) , Nivolumab) combined with the targeted anticancer drug Cabometyx (cabozantinib, cabozantinib) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

In terms of US regulation, the FDA approved the Opdivo+Cabometyx program in January 2021 for the first-line treatment of patients with advanced RCC.

Dana Walker, vice president of BMS genitourinary cancer development project, said: "In recent years, we have seen changes in the field of renal cell carcinoma treatment, and many advances have been made to help improve the prognosis of patients.

The approval of the US FDA and the positive review opinions of the EU CHMP are based on the results of the key Phase III CheckMate-9ER trial.

The specific data are as follows: (1) In terms of OS, the Opdivo+Cabometyx group had a significantly lower risk of death by 40% compared with the Sutent group (HR=0.

In the study, the combination of Opdivo and Cabometyx was well tolerated, reflecting the known safety of immunotherapy and tyrosine kinase inhibitor (TKI) in the first-line treatment of advanced RCC.

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year.

The results of the CheckMate-9ER study clearly prove that the Opdivo and Cabometyx "immune + targeted" combination treatment program for the first-line treatment of patients with advanced or metastatic RCC, is in the key efficacy indicators of progression-free survival (PFS) and overall survival (OS) A clinically significant improvement.

The active pharmaceutical ingredient of Cabometyx is cabozantinib, which is a tyrosine kinase inhibitor (TKI) that exerts an anti-tumor effect by targeting the MET, VEGFR2 and RET signaling pathways.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to uniquely use the body's own immune system to help restore anti-tumor immunity by blocking the interaction between PD-1 and its ligands answer.

For the treatment of renal cell carcinoma (RCC), Opdivo has approved indications: (1) for patients with advanced RCC who have previously received anti-angiogenesis therapy; (2) combined with Yervoy (ipilimumab, ipilimumab, Anti-CTLA-4 monoclonal antibody) first-line treatment of patients with intermediate- or high-risk advanced RCC.

Original source: Bristol Myers Squibb Receives Positive CHMP Opinion for Opdivo? (nivolumab) in Combination with Cabometyx? (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma