Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cabometyx® (cabozantinib) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
Bristol Myers Squibb (NYSE: BMY) has received approval from the European Commission for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) as a first-line treatment for adults with advanced renal cell carcinoma (RCC). This decision follows the successful Phase 3 CheckMate -9ER trial, highlighting superior efficacy in key endpoints such as progression-free survival and overall survival compared to sunitinib. The combination treatment demonstrated manageable safety with low treatment-related discontinuations, broadening options for RCC patients in Europe.
- EC approval for Opdivo and Cabometyx combination therapy for advanced RCC.
- Superior efficacy shown in Phase 3 CheckMate -9ER trial against sunitinib.
- Flexible dosing options for Opdivo enhance treatment accessibility.
- None.
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The EC’s decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival (PFS), the primary endpoint, and objective response rate (ORR) and overall survival (OS). The combination of Opdivo and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events (TRAEs) leading to discontinuation.
“With this approval, we can now offer patients two different Opdivo-based combinations that have demonstrated significant survival benefits versus sunitinib,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Today’s milestone builds on our heritage of developing and delivering novel treatments for patients with advanced renal cell carcinoma, first with the only dual immunotherapy option, Opdivo plus Yervoy, and now with a new immunotherapy and tyrosine kinase inhibitor regimen. We look forward to working with a broad range of European stakeholders to bring Opdivo in combination with Cabometyx to patients who may benefit from this treatment.”
“The combination of nivolumab and cabozantinib pairs two proven agents for advanced renal cell carcinoma that together have shown superior efficacy across key endpoints and subgroups of patients compared to sunitinib in the CheckMate -9ER trial. Additionally, the combination’s safety profile was manageable with known protocols, leading to a low rate of treatment-related discontinuations,” said Marc-Oliver Grimm, M.D., professor of medicine and urology department head, Jena University Hospital. “With today’s approval, clinicians in the EU will be able to offer patients with advanced renal cell carcinoma an additional combination therapy that may help them achieve early control of their disease and improve survival outcomes.”
Opdivo in combination with Cabometyx was approved for RCC in the EU with a flexible dosing regimen, with the option to use either Opdivo 240 mg administered intravenously every two weeks or Opdivo 480 mg administered intravenously every four weeks in combination with Cabometyx 40 mg administered orally once daily.
In addition to the EU, Opdivo in combination with Cabometyx was approved for the first-line treatment of advanced RCC by the U.S. Food and Drug Administration in January 2021, and further applications are under review
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