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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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References

  1. Food and Drug Administration. Project Orbis. FDA.gov https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis (2019).

  2. Food and Drug Administration. The therascreen PIK3CA RGQ PCR Kit - P190001 and P190004. FDA.gov https://www.fda.gov/medical-devices/recently-approved-devices/therascreen-pik3ca-rgq-pcr-kit-p190001-and-p190004 (2019).

  3. Food and Drug Administration. Oncology Center of Excellence guidance documents. FDA.gov https://www.fda.gov/about-fda/oncology-center-excellence/oncology-center-excellence-guidance-documents (2019).

  4. Blumenthal, G. M. et al. Real-time oncology review and the assessment aid: increasing review efficiency through standardization and earlier data access. focr.org https://www.focr.org/sites/default/files/ROTR%20White%20Paper%201.pdf (2018).

  5. Usdin, S. FDA to Facilitate Access to Unapproved Drugs. biocentury.com https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs (2018).

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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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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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