FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy

On October 9, 2015, the U.S. Food and Drug Administration expanded the nivolumab metastatic non-small cell lung cancer (NSCLC) indication to include patients with nonsquamous NSCLC after a 3.25-month review timeline. Approval was based on demonstration of an improvement in overall survival (OS) in a...

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Vydáno v:Oncologist
Hlavní autoři: Kazandjian, Dickran, Suzman, Daniel L., Blumenthal, Gideon, Mushti, Sirisha, He, Kun, Libeg, Meredith, Keegan, Patricia, Pazdur, Richard
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2016
Témata:
Regulatory Issues: FDA
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC4861371/
https://ncbi.nlm.nih.gov/pubmed/26984449
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2015-0507
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