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Bristol-Myers' Opdivo, Yervoy combo therapy wins EU approval for kidney cancer


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Bristol-Myers' Opdivo, Yervoy combo therapy wins EU approval for kidney cancer

The European Commission has approved a combination of Bristol-Myers Squibb Co.'s cancer medicines Opdivo and Yervoy to treat a certain kind of kidney cancer.

The New York-based biopharmaceutical giant said in its Jan. 14 news release that the approval was given as an initial treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

Advanced renal cell carcinoma is a cancer that starts in small tubes in the kidney. Patients are classified as intermediate- or poor-risk depending on their chances of being cured. About 36% of patients with advanced renal cell carcinoma survive beyond a year, according to the American Cancer Society.

The approval for the immuno-oncology combination therapy is the first of its kind for patients with this type of kidney cancer in the European Union. The U.S. Food and Drug Administration approved the combination for the same indication in April 2018.

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The European regulator's decision is based on results from a phase 3 study called CheckMate -214, which showed that patients on the combination therapy experienced significantly better improvements in their physical, emotional and functional well-being when compared to those who received Pfizer Inc.'s Sutent, or sunitinib.

Opdivo is an immuno-oncology drug that blocks the PD-1 arm of healthy cells from latching onto a tumor cell's arm, stopping the spread of the disease. Yervoy is an anti-CTLA-4 therapy that strengthens the immune system and prompts T-cells to fight cancer.

Europe's Committee for Medicinal Products for Human Use adopted a positive opinion for the Opdivo and Yervoy combination to treat renal cell carcinoma in November 2018, after re-examining a negative opinion it gave in July of the same year. The U.K. National Institute for Health and Care Excellence in December 2018 advised against recommending the combination for treating kidney cancer.