Posted from: Monday, December 28, 2015 - 10:10 AM - Present

Keytruda Label Expanded

December 18, 2015 – The U.S. Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for an expanded indication.  Manufactured by Merck, Keytruda is a first-line treatment of patients with unresectable or metastatic melanoma and a human programmed death receptor-1 (PD-1)-blocking antibody that helps the body’s immune system attack cancer cells. Keytruda was originally approved on Septeeember 4, 2014, for the second- or third-line treatment of patients with unresectable or metastatic melanoma. In October 2015, the FDA provided an expanded approval of Keytruda as a later-line option for the treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death receptor-ligand1 (PD-L1) as determined by an FDA-approved test. The recommended dose for all indications is 2mg/kg by intravenous infusion every three weeks.

 

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Last Updated Monday, May 29, 2017 - 10:35 AM.