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CCR Drug Updates

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Gwynn Ison
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: Gwynn.Ison@fda.hhs.gov
Lynn J. Howie
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Laleh Amiri-Kordestani
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Lijun Zhang
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Shenghui Tang
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Rajeshwari Sridhara
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Vadryn Pierre
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Rosane Charlab
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Anuradha Ramamoorthy
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Pengfei Song
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Fang Li
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Todd R. Palmby
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Xiao Hong Chen
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Sharon L. Kelly
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Kumar G. Janoria
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Anamitro Banerjee
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Okponanabofa Eradiri
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Jeannette Dinin
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William F. Pierce
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Amna Ibrahim
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Paul G. Kluetz
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Gideon M. Blumenthal
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Julia A. Beaver
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Richard Pazdur
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DOI: 10.1158/1078-0432.CCR-18-0042 Published September 2018
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ARTICLE USAGE: April 2018 to January 2021

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Total951819283122

Cited By

Article Information

Volume 24, Issue 17, pp. 4066-4071

DOI 
https://doi.org/10.1158/1078-0432.CCR-18-0042
PubMed 
29650751

Published By 
American Association for Cancer Research
Print ISSN 
1078-0432
Online ISSN 
1557-3265
History 
  • Received January 19, 2018
  • Revision received March 23, 2018
  • Accepted April 10, 2018
  • Published first April 12, 2018.

Article Versions

  • Previous version (April 12, 2018 - 07:54).
  • Previous version (July 11, 2018 - 06:46).
  • You are viewing the most recent version of this article.
Copyright & Usage 
©2018 American Association for Cancer Research.

Author Information

  1. Gwynn Ison*,
  2. Lynn J. Howie,
  3. Laleh Amiri-Kordestani,
  4. Lijun Zhang,
  5. Shenghui Tang,
  6. Rajeshwari Sridhara,
  7. Vadryn Pierre,
  8. Rosane Charlab,
  9. Anuradha Ramamoorthy,
  10. Pengfei Song,
  11. Fang Li,
  12. Jingyu Yu,
  13. Wimolnut Manheng,
  14. Todd R. Palmby,
  15. Soma Ghosh,
  16. Hisani N. Horne,
  17. Eunice Y. Lee,
  18. Reena Philip,
  19. Kaushalkumar Dave,
  20. Xiao Hong Chen,
  21. Sharon L. Kelly,
  22. Kumar G. Janoria,
  23. Anamitro Banerjee,
  24. Okponanabofa Eradiri,
  25. Jeannette Dinin,
  26. Kirsten B. Goldberg,
  27. William F. Pierce,
  28. Amna Ibrahim,
  29. Paul G. Kluetz,
  30. Gideon M. Blumenthal,
  31. Julia A. Beaver, and
  32. Richard Pazdur
  1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  1. ↵*Corresponding Author:
    Gwynn Ison, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Phone 301-796-4057; Fax: 301-796-9849; E-mail: Gwynn.Ison{at}fda.hhs.gov
  1. G. Ison and L.J. Howie contributed equally to this article.

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Clinical Cancer Research: 24 (17)
September 2018
Volume 24, Issue 17
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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Clin Cancer Res September 1 2018 (24) (17) 4066-4071; DOI: 10.1158/1078-0432.CCR-18-0042

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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Clin Cancer Res September 1 2018 (24) (17) 4066-4071; DOI: 10.1158/1078-0432.CCR-18-0042
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