Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer

On March 11, 2016, after an expedited 5-month review, the U.S. Food and Drug Administration expanded the crizotinib metastatic non-small cell lung cancer (mNSCLC) indication to include the treatment of patients whose tumors harbor a ROS1 rearrangement. The approval was based on a clinically meaningf...

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Detalles Bibliográficos
Autores principales: Kazandjian, Dickran, Blumenthal, Gideon M., Luo, Lola, He, Kun, Fran, Ingrid, Lemery, Steven, Pazdur, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AlphaMed Press 2016
Materias:
Regulatory Issues: FDA
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4978556/
https://www.ncbi.nlm.nih.gov/pubmed/27328934
http://dx.doi.org/10.1634/theoncologist.2016-0101

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4978556/
https://www.ncbi.nlm.nih.gov/pubmed/27328934
http://dx.doi.org/10.1634/theoncologist.2016-0101

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