In 2017, FDA Oncology approved 17 new drug and biologic applications, 32 supplemental drug and biologic applications, and two biosimilar applications in oncology. These actions included landmark approvals of two chimeric antigen receptor T cell therapies and the first site-agnostic, biomarker-defined approval. Three next-generation sequencing 'oncopanels' designed to detect hundreds of somatic genetic aberrations were also approved.
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Acknowledgements
The authors thank Kirsten Goldberg from the Office of Hematology and Oncology Products, FDA, for her assistance with editing this manuscript.
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Supplementary table 1
Summary of FDA oncology drug approvals in 2017 (in decreasing chronological order) (PDF 195 kb)
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Blumenthal, G., Pazdur, R. Approvals in 2017: gene therapies and site-agnostic indications. Nat Rev Clin Oncol 15, 127–128 (2018). https://doi.org/10.1038/nrclinonc.2018.11
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DOI: https://doi.org/10.1038/nrclinonc.2018.11
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