MSD has received US Food and Drug Administration (FDA) approval for its anti-programmed death receptor-1 (PD-1) therapy, Keytruda (pembrolizumab), for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
This is intended for adults whose tumours express PD-L1 with a combined positive score [CPS] ≥1 as measured by a test approved by the US regulator.
It is supported by data from the pivotal Phase III KEYNOTE-689 trial, allowing the use of Keytruda monotherapy as a neoadjuvant treatment and continued as an adjuvant treatment in conjunction with radiotherapy, with or without cisplatin, followed by the therapy alone.
Project Orbis, an initiative of the agency’s Oncology Center of Excellence, facilitated a concurrent review of Keytruda.
Marketing authorisation applications are currently under review by health authorities in Australia, Brazil, Canada, Israel, Singapore and Switzerland.
Regulatory authorities in Europe and Japan are reviewing applications for Keytruda.
MSD Research Laboratories global clinical development oncology head and senior vice-president Dr Marjorie Green stated: “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.
“Based on these trial results, Keytruda as part of this regimen shows potential to change long-standing standards of care for treating certain patients with locally advanced HNSCC.”
Keytruda is designed to enhance the immune system's ability to detect and combat tumour cells.
This humanised monoclonal antibody prevents PD-1 from interacting with its ligands, PD-L1 and PD-L2, leading to the activation of T lymphocytes, impacting both tumour and healthy cells.
MSD's Keytruda is being studied in more than 1,600 trials across various cancers and treatment settings.
MSD has also secured FDA approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus lower respiratory tract disease in neonates and infants.
