Merck's Keytruda wins FDA approval as combination therapy for kidney cancer

The U.S. Food and Drug Administration has approved Merck & Co Inc’s cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday.

The drug was approved in combination with Pfizer Inc’s Inlyta to treat advanced renal cell carcinoma.

The approval, which comes two months ahead of expectations, allows this combination therapy to get an early launch ahead of other rival products, Cowen analyst Yaron Werber said, after the company received FDA approval on Friday.

The Keytruda/Inlyta combination could provide serious competition for Bristol-Myers Squibb Co’s immunotherapy combination of Opdivo and Yervoy, currently considered a gold standard for previously untreated advanced kidney cancer patients.

Keytruda’s sales have surged past Opdivo’s, and the drug is expected to bring more than $10 billion for Merck this year, according to IBES data from Refinitiv.

Merck’s Keytruda, which works by increasing the ability of the patient’s immune system to help detect and fight tumor cells, has been its most important revenue growth driver with its domination of the lucrative lung cancer space.

According to results from the study posted in February, about 90 percent of the patients who received the Keytruda/Inlyta combination were alive after 12 months, compared with about 78 percent of patients who were alive after a year when treated with an older Pfizer standalone therapy Sutent.

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