Posted from: Tuesday, September 27, 2016 - 02:16 PM - Present

Labeling Extended for Keytruda

August 5, 2016 – The FDA approved a new indication for Merck’s Keytruda (pembrolizumab) under the accelerated approval process. Keytruda is approved for patients who have recurring or metastatic head or neck squamous cell carcinoma (HNSCC). It is an intravenous (IV) drug that will be used during or following platinum-based therapy that is not controlling the cancer. A humanized monoclonal antibody, Keytruda blocks a protein (PD-L1), to enhance immune response. It was previously indicated for treating unresectable or metastatic melanoma and metastatic non-small cell lung cancer (NSCLC) that expresses PD-L1 and that has progressed during or after platinum-containing chemotherapy. NSCLC patients must be tested for PD-L1 before beginning Keytruda. To treat HNSCC, 200mg of Keytruda is infused over a 30-minute period once every three weeks. HNSCC patients will not need PD-L1 testing.

 

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Last Updated Wednesday, November 22, 2017 - 05:41 PM.