FDA approves new indication for Merck’s Keytruda
Merck has received the Food and Drug Administration’s green light for another indication for Keytuda. The drug now is approved as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with a certain combined positive score whose disease progressed after one or more prior therapies.
“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” said 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, providing an important new monotherapy option for physicians and patients in the United States.”
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. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, activating T lymphocytes, which may affect both tumor cells and healthy cells.
Keytruda is indicated for melanoma, non-small cell lung cancer; small cell lung cancer, head and neck cancer, classical hodgkin lymphoma; primary mediastinal large B-cell lymphoma; urothelial carcinoma; microsatellite instability-high cancer; gastric cancer; esophageal cancer; cervical cancer; hepatocellular carcinoma; merkel cell carcinoma; and renal cell carcinoma.
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