Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker

Author:

Emancipator Kenneth

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference46 articles.

1. KEYTRUDA® (pembrolizumab) for injection, for intravenous use. Whitehouse Station, NJ, USA: Merck Sharp & Dohme, Corp. 10/2020.

2. Keytruda (pembrolizumab) 50 mg powder for concentrate for solution for infusion (summary of product characteristics). Hoddesdon, UK: Merck Sharp & Dohme Limited; 2020.

3. Sul J, Blumenthal GM, Jiang X, He K, Keegan P, Pazdur R. FDA approval summary: pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1. Oncologist. 2016;21:643–50.

4. Dolled-Filhart M, Roach C, Toland G, Stanforth D, Jansson M, Lubiniecki GM, et al. Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1. Arch Pathol Lab Med. 2016;140:1243–9.

5. US Department of Health and Services. In vitro companion diagnostic devices. Washington, DC: US Department of Health and Services; 2014.

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