FDA Approves Pembrolizumab for Advanced Esophageal Squamous Cell Cancer with PD-L1 Expression
- The FDA approved pembrolizumab for patients with recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of 10 or higher.
- Clinical trials KEYNOTE-181 and KEYNOTE-180 demonstrated significant survival benefits, with median overall survival of 10.3 months versus 6.7 months for control treatment.
- The approval includes a companion diagnostic test to identify eligible patients based on PD-L1 expression levels using the PD-L1 IHC 22C3 pharmDx kit.
- The recommended dosing regimen is pembrolizumab 200 mg administered intravenously every 3 weeks until disease progression or unacceptable toxicity.
Merck Sharp & Dohme LLC
Posted 12/2/2015