EC approves combination treatment for kidney cancer

pharmafile | March 31, 2021 | News story | Research and Development Cancer, Europe, oncology 

The European Commission (EC) has approved Ipsen’s Cabometyx in combination with Opdivo as a first-line treatment for advanced renal cell carcinoma (aRCC).

The approval is based on findings from the Phase III CheckMate-9ER trial, in which Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) demonstrated significant improvements across all efficacy endpoints. Patients treated with the drug combination reported significantly better health-related quality of life, overall survival and disease control rates, with a lower rate of discontinuation compared to sunitinib.

The EC approval marks the first for Cabometyx in combination with another therapy in Europe and the third indication of Cabometyx in RCC. The decision also allows for the marketing of Cabometyx in combination with Opdivo in this indication in all 27 member states of the EU, Norway, Liechtenstein, and Iceland.

Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen, said: “Today’s EC approval for the use of Cabometyx in combination with Opdivo provides an important new first-line treatment option for patients living with advanced renal cell carcinoma. At Ipsen, we’re proud that this, now approved, treatment option not only addresses key efficacy benefits, but also the need to maintain quality of life for patients.

“We look forward to collaborating with a broad range of European stakeholders to bring this unique combination to eligible patients living with advanced renal cell carcinoma.”

There are over 400,000 new cases of kidney cancer diagnosed worldwide each year and of these, RCC is the most common type of kidney cancer, accounting for approximately 90% of cases. It is twice as common in men, and male patients account for over two thirds of deaths. If detected in the early stages, the five-year survival rate is high, but for patients with advanced or late-stage metastatic RCC the survival rate is much lower, around 12%, with no identified cure for this disease.

Marc-Oliver Grimm M.D., Professor of Medicine and Urology Department Head at Jena University Hospital, 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.”

Kat Jenkins

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