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CCR Drug Updates

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer

Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani and Julia A. Beaver
Sakar Wahby
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: sakar.wahby@fda.hhs.gov
Lola Fashoyin-Aje
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • ORCID record for Lola Fashoyin-Aje
Christy L. Osgood
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Joyce Cheng
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Mallorie H. Fiero
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Lijun Zhang
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Shenghui Tang
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Salaheldin S. Hamed
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Pengfei Song
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Rosane Charlab
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Sarah E. Dorff
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Tiffany K. Ricks
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Kimberly Barnett-Ringgold
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Jeannette Dinin
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Kirsten B. Goldberg
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Richard Pazdur
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Laleh Amiri-Kordestani
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Julia A. Beaver
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DOI: 10.1158/1078-0432.CCR-20-3119 Published April 2021
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Article Information

Volume 27, Issue 7, pp. 1850-1854

DOI 
https://doi.org/10.1158/1078-0432.CCR-20-3119
PubMed 
33168656

Published By 
American Association for Cancer Research
Print ISSN 
1078-0432
Online ISSN 
1557-3265
History 
  • Received August 25, 2020
  • Revision received October 8, 2020
  • Accepted November 5, 2020
  • Published first November 9, 2020.

Article Versions

  • Previous version (November 9, 2020 - 06:00).
  • Previous version (March 3, 2021 - 05:52).
  • You are viewing the most recent version of this article.
Copyright & Usage 
©2020 American Association for Cancer Research.

Author Information

  1. Sakar Wahby1,*,
  2. Lola Fashoyin-Aje1,
  3. Christy L. Osgood1,
  4. Joyce Cheng1,
  5. Mallorie H. Fiero1,
  6. Lijun Zhang1,
  7. Shenghui Tang1,
  8. Salaheldin S. Hamed1,
  9. Pengfei Song1,
  10. Rosane Charlab1,
  11. Sarah E. Dorff1,
  12. Tiffany K. Ricks1,
  13. Kimberly Barnett-Ringgold1,
  14. Jeannette Dinin1,
  15. Kirsten B. Goldberg1,2,
  16. Marc R. Theoret1,2,
  17. Richard Pazdur1,2,
  18. Laleh Amiri-Kordestani1, and
  19. Julia A. Beaver1
  1. 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  2. 2Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  1. ↵*Corresponding Author:
    Sakar Wahby, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Building 22, Room 2322, Silver Spring, MD 20993. Phone: 240-402-5364; E-mail: sakar.wahby{at}fda.hhs.gov
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Clinical Cancer Research: 27 (7)
April 2021
Volume 27, Issue 7
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FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer
Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani and Julia A. Beaver
Clin Cancer Res April 1 2021 (27) (7) 1850-1854; DOI: 10.1158/1078-0432.CCR-20-3119

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FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer
Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani and Julia A. Beaver
Clin Cancer Res April 1 2021 (27) (7) 1850-1854; DOI: 10.1158/1078-0432.CCR-20-3119
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