FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Keytruda Gets FDA Nod for Kidney Cancer

April 30, 2019

The FDA approved Merck’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) for treatment of patients with advanced renal cell carcinoma.

The expanded approval comes after Merck reported data from a Phase III trial, which found that Keytruda cut the risk of patient death nearly in half.

Keytruda is already a blockbuster for Merck as a lung cancer drug, with $2 billion in sales in the fourth quarter of 2018 alone.

Advanced renal cell carcinoma is the most common form of kidney cancer.

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