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Approvals in 2022: overall survival, dose optimization, new approvals and beyond

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From Nature Reviews Clinical Oncology

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In 2022, the FDA approved numerous new drug and biologic agents, including targeted small molecules, immunotherapeutics, a gene therapy and a radiopharmaceutical. Several drug development challenges were also addressed, and key focus areas for the FDA Oncology Center of Excellence included ongoing monitoring of the Accelerated Approval programme and drug dose optimization.

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References

  1. Tew, W. P., Lacchetti, C. & Kohn, E. C. Poly(ADP-ribose) polymerase inhibitors in the management of ovarian cancer: ASCO guideline rapid recommendation update. J. Clin. Oncol. 40, 3878–3881 (2022).

    Article  CAS  PubMed  Google Scholar 

  2. Richardson, N. C., Kasamon, Y., Pazdur, R. & Gormley, N. The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint. Lancet Oncol. 23, 563–566 (2022).

    Article  CAS  PubMed  Google Scholar 

  3. Secura Bio, Inc.; Withdrawal of approval of relapsed or refractory follicular lymphoma indication for COPIKTRA. 87 Fed. Reg. 21888 (13 April 2022).

  4. FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/159920/download (21 April 2022).

  5. FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/164051/download (23 September 2022).

  6. FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/164050/download (22 September 2022).

  7. FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/164049/download (22 September 2022).

  8. FDA. Conversations on Cancer. fda.gov, https://www.fda.gov/about-fda/project-community/conversations-cancer (accessed 13 January 2023).

  9. FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/164232/download (28 October 2022).

  10. FDA. Oncology Center of Excellence guidance documents. fda.gov, https://www.fda.gov/media/157635/download (6 April 2022).

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Acknowledgements

The authors thank P. Kluetz and M. Theoret (both based at the US FDA) for their assistance with writing this manuscript.

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Authors and Affiliations

  1. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Deepti Telaraja & Nicole Gormley

  2. Oncology Center or Excellence, US Food and Drug Administration, Silver Spring, MD, USA

    Richard Pazdur

Authors
  1. Deepti Telaraja
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  2. Nicole Gormley
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  3. Richard Pazdur
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Corresponding author

Correspondence to Nicole Gormley.

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The authors declare no competing interests.

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Telaraja, D., Gormley, N. & Pazdur, R. Approvals in 2022: overall survival, dose optimization, new approvals and beyond. Nat Rev Clin Oncol 20, 207–208 (2023). https://doi.org/10.1038/s41571-023-00741-6

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