In 2016, FDA Oncology approved five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews, and 11 approvals of breakthrough-designated therapies. The FDA also approved five companion diagnostics, including a liquid biopsy test. One new anti-PD-L1 antibody was approved, along with six supplementary approvals of anti-PD-1/PD-L1 antibodies.
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The authors would like to thank Kirsten Goldberg from the Office of Hematology and Oncology Products, FDA for her assistance with editing this manuscript.
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Summary of FDA oncology drug approvals in 2016 (PDF 76 kb)
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Blumenthal, G., Pazdur, R. Approvals in 2016: the march of the checkpoint inhibitors. Nat Rev Clin Oncol 14, 131–132 (2017). https://doi.org/10.1038/nrclinonc.2017.15
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DOI: https://doi.org/10.1038/nrclinonc.2017.15
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