EU and US could reach trade deal this weekend - Reuters
FDA approves Merck’s Keytruda for locally advanced head and neck cancer
NEW YORK - The U.S. Food and Drug Administration has approved Merck’s (NYSE: MRK) Keytruda for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, the company announced Friday. Merck, a prominent player in the pharmaceuticals industry with annual revenue of $63.9 billion, continues to demonstrate strong market performance. According to InvestingPro analysis, the company appears undervalued at current market prices, suggesting potential upside for investors.
The approval makes Keytruda the first perioperative anti-PD-1 treatment regimen for this patient population. The therapy will be administered as a single agent before surgery (neoadjuvant), continued after surgery (adjuvant) in combination with radiotherapy with or without cisplatin, and then as a single agent.
The FDA’s decision was based on results from the Phase 3 KEYNOTE-689 trial, which showed that Keytruda reduced the risk of event-free survival events by 30% compared to standard of care in patients whose tumors expressed PD-L1. Median event-free survival was 59.7 months in the Keytruda arm versus 29.6 months in the standard of care arm. This development further strengthens Merck’s market position, with the company maintaining an impressive 77% gross profit margin and a "GREAT" financial health score according to InvestingPro’s comprehensive analysis.
"With this approval, we can now offer appropriate patients with resectable locally advanced head and neck squamous cell carcinoma a new treatment regimen that has been shown to reduce the risk of recurrence, progression, or death by 30%, compared with standard of care adjuvant chemoradiotherapy or radiotherapy alone," said Dr. Ravindra Uppaluri, the study’s principal investigator.
The most common adverse reactions reported in patients receiving Keytruda included stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), and dysphagia (29%).
This approval was reviewed under Project Orbis, an FDA initiative that provides concurrent review of oncology drugs among international partners. Marketing authorization applications for Keytruda based on the KEYNOTE-689 results are under review by health authorities worldwide.
Head and neck cancer is estimated to affect approximately 72,680 new patients in the U.S. in 2025, with more than 16,680 deaths expected from the disease.
The information in this article is based on a press release statement from Merck.
In other recent news, Merck & Co. has initiated a Phase 3 clinical trial for its dengue vaccine candidate, V181. This trial will enroll approximately 12,000 participants aged 2 to 17 across multiple sites in the Asia-Pacific region, aiming to evaluate the vaccine’s safety, immunogenicity, and efficacy. Meanwhile, Merck Animal Health has received a positive opinion from the European Medicines Agency for its canine dermatitis drug, NUMELVI, which could become the first second-generation JAK inhibitor for dogs if approved by the European Commission in 2025. In other developments, Cantor Fitzgerald has maintained a Neutral rating on Merck stock with a price target of $85, citing uncertainties surrounding the dosage regimen of Merck’s Gardasil vaccine. Analyst Carter Gould noted that potential changes in dosage recommendations by the Advisory Committee on Immunization Practices could impact U.S. sales estimates. However, Gould suggested that current clinician behaviors and pricing strategies might mitigate potential sales declines. Investors are closely watching the upcoming ACIP meeting in June, where decisions regarding Gardasil’s dosage regimen are expected. These developments highlight Merck’s ongoing efforts in both human and animal health sectors.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.