Merck Gets FDA Approval to Expand Use of Its Top-Selling Drug, Keytruda

Merck (MRK) has received the go-ahead to expand use of its blockbuster cancer drug, Keytruda.

The Food and Drug Administration (FDA) has approved Keytruda’s use for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express the protein PD-L1. 

The study’s overall principal investigator, Dr. Ravindra Uppaluri, said the approval “represents a potentially significant shift in how we manage this disease.” Dr. Uppaluri added Keytruda “has been shown to reduce the risk of recurrence, progression, or death by 30%, compared with standard of care adjuvant chemoradiotherapy or radiotherapy alone.”

Merck noted that it’s estimated that in 2025, there will be approximately 72,680 new cases of head and neck cancer diagnosed, and more than 16,680 deaths from the disease.

Keytruda is the company’s best-selling drug, with first-quarter revenue of $7.2 billion, making up nearly half of its total sales.

Entering Friday trading, shares of Merck were down about 18% year-to-date.