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Keytruda Approval History

Keytruda (pembrolizumab) is a human PD-1 (programmed death receptor-1)-blocking antibody indicated for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

Development History and FDA Approval Process for Keytruda

DateArticle
Oct 24, 2016Approval FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer
Aug  5, 2016Approval FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Dec 18, 2015Approval FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
Oct  2, 2015Approval FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer
Sep  4, 2014Approval FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma
Sep  2, 2014Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab
Jun 30, 2014Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma

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