Merck Gets FDA Approval For Keytruda To Treat A Broader Population Of Head And Neck Cancer Patients: Retail Stays Bullish

In the U.S., it is estimated there will be approximately 72,680 new cases of head and neck cancer diagnosed and more than 16,680 deaths from the disease in 2025, Merck said.

Merck (MRK) on Friday said that the U.S. Food and Drug Administration (FDA) has approved its blockbuster drug Keytruda for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, a protein that allows them to evade immune attack.

The approval is based on data from a late-stage trial that studied Keytruda in patients before surgery, followed by continued treatment after surgery in combination with standard of care (SOC) radiotherapy, with or without cisplatin, and then Keytruda alone.

The study demonstrated that the regimen reduced the risk of disease recurrence, progression, or death by 30% in patients whose tumors expressed PD-L1, compared to standard-of-care adjuvant chemoradiotherapy or radiotherapy alone.

In the U.S., Keytruda is already approved as monotherapy and in combination regimens for certain patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), including as a single agent for the treatment of patients with recurrent or metastatic HNSCC who have disease progression on or after platinum-containing chemotherapy.

Head and neck cancer describes several different tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. In the U.S., it is estimated there will be approximately 72,680 new cases of head and neck cancer diagnosed and more than 16,680 deaths from the disease in 2025, Merck said.

“As the first perioperative anti-PD-1 treatment option for appropriate patients with resectable locally advanced head and neck squamous cell carcinoma, this new treatment regimen has the potential to shift the treatment paradigm for patients and their families affected by this disease,” said Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories.

Keytruda is Merck’s blockbuster drug, which brought in $7.205 billion in sales in the first quarter of 2025, up from $6.947 billion in the corresponding quarter of 2024. Keytruda accounted for 46% of the company’s total sales in the quarter.

On Stocktwits, retail sentiment around Merck remained unmoved within the ‘bullish’ territory over the past 24 hours while message volume remained at ‘high’ levels.

MRK stock is down by 17% this year and about 37% in the past 12 months.

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