The FDA has granted approval for KEYTRUDA (pembrolizumab) as a neoadjuvant and adjuvant treatment for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.

This marks the first perioperative anti-PD-1 treatment regimen approved for HNSCC in six years, offering a new option for patients.

The approval is based on the Phase 3 KEYNOTE-689 trial, which demonstrated a 30% reduction in the risk of disease recurrence, progression, or death with KEYTRUDA compared to standard care.

In the KEYNOTE-689 trial involving 714 patients, the median event-free survival was significantly higher at 59.7 months for the Keytruda group versus 29.6 months for the control group.

Patients in the trial received 200 mg of pembrolizumab every three weeks for two cycles before surgery, followed by three cycles after surgery and then 12 cycles as maintenance therapy.

Dr. Ravindra Uppaluri, the study's principal investigator, emphasized that this treatment could significantly alter disease management for patients with locally advanced HNSCC.

The recommended dosing for Keytruda is either 200 mg every three weeks or 400 mg every six weeks, with specific instructions for administration alongside chemotherapy.

Head and neck cancer remains a significant health concern, with an estimated 72,680 new cases and 16,680 deaths expected in the U.S. by the end of 2025.

Keytruda's prescribing information warns of immune-related side effects and potential risks to unborn babies, necessitating careful monitoring.

Immune-mediated adverse reactions can occur with KEYTRUDA, including severe conditions affecting various organ systems, requiring careful management.

The findings from the trial suggest that KEYTRUDA may shift the treatment paradigm for HNSCC, according to Dr. Marjorie Green from Merck.

Despite the drug's success, Merck's shares were down approximately 18% year-to-date as of recent trading.