The Food and Drug Administration has approved Keytruda for recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus in certain patients.
BY Kristie L. Kahl
The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for recurrent locally advanced or metastatic esophageal squamous cell carcinoma. The agent’s indication is approved for patients whose tumors express PD-L1 (a combined positive score of 10 or more) with disease progression after one or more prior lines of systemic therapy, according to Merck, the immunotherapy drug’s manufacturer.
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. The approval was based on data from two trials:
- KEYNOTE-181: a multicenter, randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally advanced or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced disease.
- KEYNOTE-180: a multicenter, non-randomized, open-label trial that enrolled 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease.
“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” Dr. Jonathan Cheng, vice president of oncology clinical research at Merck Research Laboratories, said in a press release.
“With this approval, Keytruda is now the first anti-PD-1 therapy approved for the treatment of previously-treated patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (a combined positive score of 10 or more), providing an important new monotherapy option for physicians and patients in the United States,” he added.
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