Tempering Expectations of Breakthrough Therapy Designated Drugs
From the interview:
A recent study published in the Journal of Clinical Oncology (online June 20, 2018; doi:10.1200/JCO/2017.77.1592) sought to evaluate the United States Food and Drug Administration (FDA) breakthrough therapy designation for novel cancer agents. The major conclusion of the study was that little evidence exists showing that breakthrough therapy designated drugs offer improvements in efficacy, safety, or novelty compared with non-breakthrough therapy designated drugs.
Journal of Clinical Pathways spoke with Jonathan J Darrow, SJD, JD, MBA, a faculty member at Harvard and the senior author of the study, to shed further light on this finding and divulge its larger implications.
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