Merck Receives FDA Approval for Keytruda in Head, Neck Cancers

Merck has received FDA approval to expand the use of its top-selling cancer drug Keytruda for adults with resectable locally advanced head and neck squamous cell carcinoma expressing the PD-L1 protein. This approval, based on a Phase 3 trial, allows Keytruda to be used as a neoadjuvant treatment before surgery and as an adjuvant treatment after surgery, reducing the risk of recurrence, progression, or death by 30% compared to standard care. Merck also recently gained FDA authorization for Enflonsia, a preventative antibody shot protecting infants up to age one from respiratory syncytial virus (RSV), a serious respiratory infection. Meanwhile, GSK is seeking European Medicines Agency approval to expand the use of its RSV vaccine Arexvy to adults aged 18 and older, with a decision expected in the first half of 2026. These developments highlight ongoing efforts by pharmaceutical companies to address serious infectious diseases and cancer with expanded treatment options. Merck’s Keytruda remains a significant revenue driver, despite the company’s shares being down year-to-date.