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FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur and Julia A. Beaver
Preeti Narayan
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: preeti.narayan@fda.hhs.gov
Tatiana M. Prowell
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • ORCID record for Tatiana M. Prowell
Jennifer J. Gao
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Laura L. Fernandes
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • ORCID record for Laura L. Fernandes
Emily Li
2Oncology Center of Excellence Summer Scholars Program, Silver Spring, Maryland.
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Xiling Jiang
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Junshan Qiu
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Jianghong Fan
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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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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Jingyu Yu
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Xinyuan Zhang
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Bellinda L. King-Kallimanis
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Wei Chen
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Tiffany K. Ricks
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Yutao Gong
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Xing Wang
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Katherine Windsor
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Steve Y. Rhieu
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Gerlie Geiser
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Anamitro Banerjee
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Xiaohong Chen
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Francisca Reyes Turcu
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Deb K. Chatterjee
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Anand Pathak
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Jeffrey Seidman
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Soma Ghosh
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Reena Philip
3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Kirsten B. Goldberg
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Paul G. Kluetz
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
4Oncology Center of Excellence, 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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Laleh Amiri-Kordestani
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Marc R. Theoret
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
4Oncology 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.
4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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Julia A. Beaver
1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
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DOI: 10.1158/1078-0432.CCR-20-3652 Published April 2021
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Article Information

Volume 27, Issue 7, pp. 1842-1849

DOI 
https://doi.org/10.1158/1078-0432.CCR-20-3652
PubMed 
33168657

Published By 
American Association for Cancer Research
Print ISSN 
1078-0432
Online ISSN 
1557-3265
History 
  • Received September 16, 2020
  • Revision received October 19, 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. Preeti Narayan1,*,
  2. Tatiana M. Prowell1,
  3. Jennifer J. Gao1,4,
  4. Laura L. Fernandes1,
  5. Emily Li2,
  6. Xiling Jiang1,
  7. Junshan Qiu1,
  8. Jianghong Fan1,
  9. Pengfei Song1,
  10. Jingyu Yu1,
  11. Xinyuan Zhang1,
  12. Bellinda L. King-Kallimanis1,
  13. Wei Chen1,
  14. Tiffany K. Ricks1,
  15. Yutao Gong1,
  16. Xing Wang1,
  17. Katherine Windsor1,
  18. Steve Y. Rhieu1,
  19. Gerlie Geiser1,
  20. Anamitro Banerjee1,
  21. Xiaohong Chen1,
  22. Francisca Reyes Turcu3,
  23. Deb K. Chatterjee3,
  24. Anand Pathak3,
  25. Jeffrey Seidman3,
  26. Soma Ghosh3,
  27. Reena Philip3,
  28. Kirsten B. Goldberg1,4,
  29. Paul G. Kluetz1,4,
  30. Shenghui Tang1,
  31. Laleh Amiri-Kordestani1,
  32. Marc R. Theoret1,4,
  33. Richard Pazdur1,4, and
  34. Julia A. Beaver1,4
  1. 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  2. 2Oncology Center of Excellence Summer Scholars Program, Silver Spring, Maryland.
  3. 3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
  4. 4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  1. ↵*Corresponding Author:
    Preeti Narayan, U.S. Food and Drug Administration, WO22 Room 2331, 10903 New Hampshire Avenue, Silver Spring, MD 20993. Phone: 240-402-9523; E-mail: preeti.narayan{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: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur and Julia A. Beaver
Clin Cancer Res April 1 2021 (27) (7) 1842-1849; DOI: 10.1158/1078-0432.CCR-20-3652

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FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur and Julia A. Beaver
Clin Cancer Res April 1 2021 (27) (7) 1842-1849; DOI: 10.1158/1078-0432.CCR-20-3652
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