Approvals in 2019: international review and a new agnostic molecular entity

In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

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Acknowledgements

The authors would like to thank Kirsten Goldberg for her assistance with editing this manuscript. FDA does not cite publications because we evaluate the source data and base our approvals on the data that are submitted to the Agency (see Related links).

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Correspondence to Harpreet Singh.

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The authors declare no competing interests.

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Related links

FDA-approved drugs: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

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Singh, H., Blumenthal, G. & Pazdur, R. Approvals in 2019: international review and a new agnostic molecular entity. Nat Rev Clin Oncol 17, 130–131 (2020). https://doi.org/10.1038/s41571-020-0336-8

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