New Keytruda Indication Approved for Esophageal Cancer
July 30, 2019 – The U.S. FDA has approved a new indication for Merck’s Keytruda® (pembrolizumab), bringing the product’s total number of approved uses to 21. Keytruda is now indicated to treat recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in patients whose tumors express PD-L1 and whose disease has progressed following one or more prior lines of systemic therapy.
One of the most common forms of esophageal cancer, ESCC typically occurs in the upper and middle part of the esophagus, but can develop anywhere along the structure. Risk factors include tobacco use, heavy alcohol use, older age, and Barrett’s esophagus (a condition in which healthy cells in the lower part of the esophagus are replaced by abnormal cells, often as a consequence of chronic heartburn). The five-year survival rate for all esophageal cancers combined is poor, with the outlook typically better for patients with adenocarcinoma instead of squamous cell disease.
In a clinical study, treatment with Keytruda reduced the risk of death by 31% compared to standard treatment in the form of paclitaxel, docetaxel, or irinotecan chemotherapy. Patients enrolled in the trial had recurrent locally advanced or metastatic esophageal cancer that had progressed on or after one prior line of systemic treatment for advanced disease. Recommended dosing under the new indication is 200mg administered as an intravenous infusion over the course of 30 minutes every three weeks for up to 24 months, or until disease progression or unacceptable toxicity.