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Merck: EU agency backs Keytruda for kidney cancer

(CercleFinance.com) - Merck's immunotherapy Keytruda has been recommended for approval by European regulators for the treatment of kidney cancer, the US drugmaker said on Monday.


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Merck's anti-PD-1 therapy, in combination with Pfizer's Inlyta, for the first-line treatment of patients with advanced renal cell carcinoma.

This recommendation is based on findings from a pivotal Phase 3 trial, which demonstrated significant improvements in patients' overall survival, Merck said.

The prognosis for advanced renal cell carcinoma is currently poor, with a five-year survival rate of less than 10%.

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