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KCCure Urges EMA to approve Opdivo/Yervoy for European Kidney Cancer Patients

July 30, 2018

Washington, DC, – The Kidney Cancer Research Alliance(KCCure) responded to the Committee for Medicinal Products for Human Use (CHMP) recommendation against approval by the European Medicines Agency (EMA) of ipilimumab (Yervoy) combined with nivolumab (Opdivo) for the first line treatment of high and intermediate risk metastatic renal cell carcinoma (kidney cancer).

The question of single-agent versus combination therapy is relevant in kidney cancer today and we agree with CHMP that additional data showing the superiority of adding ipilimumab to nivolumab would benefit the field and broaden our understanding of how these agents work in kidney cancer. However, we don’t believe this question alone is sufficient enough to justify denying kidney cancer patients access to a treatment that offers a significant survival advantage over the current standard of care.
This combination therapy is the most significant achievement in the field of kidney cancer in over a decade, providing a profound overall survival advantage for most and for some a curative result, at an acceptable toxicity level with improved quality of life over the previous standard of care therapies. 
As an organization representing kidney cancer patients, physicians, and researchers around the globe, we implore EMA to grant access to this life-saving therapy for kidney cancer patients. 

Full text of the statement can be found here or download PDF here: KCCure statement on EMA decision PDF

Opdivo plus Yervoy was approved in April of this year by the U.S. Food and Drug Administration (FDA) for first-line treatment of metastatic Renal Cell Carcinoma (RCC) in intermediate and poor risk patients.

About KCCure: The Kidney Cancer Research Alliance (KCCure) is a grassroots organization of patients, caregivers, doctors and medical researchers dedicated to eliminating suffering and death due to kidney cancer through increased funding to accelerate research that will lead to a cure for all patients and prevent future kidney cancer diagnoses.

For more information about treatment options available for advanced kidney cancer, click here.



Dena Battle


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