BRIEF-FDA approves new monotherapy indication for Merck's Keytruda

The US Food and Drug Administration has approved Keytruda (pembrolizumab), Merck & Co’s blockbuster anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” said Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories.

“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 (CPS ≥10), providing an important new monotherapy option for physicians and patients in the United States,” Dr Cheng noted.