Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

With the Breakthrough Therapy Designation program adding to the tools that the U.S. Food and Drug Administration (FDA) has for expediting drug development, the FDA reassessed the endpoints needed for approval of transformative therapies. Although the demonstration of an improvement in overall surviv...

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Foilsithe in:Oncologist
Main Authors: Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Formáid: Artigo
Teanga:Inglês
Foilsithe: AlphaMed Press 2017
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Commentaries
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC5507655/
https://ncbi.nlm.nih.gov/pubmed/28576856
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2017-0152
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