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news.Bristol Myers Squibb has been granted approval by the European Commission (EC) for the use of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) to treat adults with advanced renal cell carcinoma (RCC).
Apart from the EU, the Opdivo-Cabometyx combination was approved for the first-line treatment of advanced RCC by the USFDA in January 2021. Credit: National Cancer Institute/Unsplash.
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Bristol Myers Squibb has been granted approval by the European Commission (EC) for the use of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) to treat adults with advanced renal cell carcinoma (RCC).
EC’s decision to approve Opdivo is based on results garnered from the Phase 3 CheckMate -9ER trial. The trial exhibited superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three main endpoints. These were progression-free survival (PFS), the primary endpoint, and objective response rate (ORR) and overall survival (OS).
Opdivo and Cabometyx combination was well tolerated, with safety replicating the known profiles of both medicines and a low rate of treatment-related adverse events (TRAEs) leading to discontinuation.
Bristol Myers Squibb genitourinary cancers development programme lead vice-president Dana Walker said: “With this approval, we can now offer patients two different Opdivo-based combinations that have demonstrated significant survival benefits versus sunitinib. 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.”
Jena University Hospital professor of medicine and urology department head Marc-Oliver Grimm said: “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. 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.”
Apart from the EU, the Opdivo-Cabometyx combination was approved for the first-line treatment of advanced RCC by the USFDA in January 2021, while further applications are under review with health authorities worldwide.
The New England Journal of Medicine published the results from the CheckMate -9ER trial in March 2021.
International Kidney Cancer Coalition chair Rachel Giles said: “With progress in research, patients are living longer with advanced kidney cancer than ever before, and so it has become increasingly important to consider how treatment impacts their daily lives. We are pleased to see the approval of a new, first-line combination for patients with advanced renal cell carcinoma that has the potential to not only control the disease but also maintain their health-related quality of life.”