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Volume 27, Issue 7, pp. 1842-1849
PubMed
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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.
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©2020 American Association for Cancer Research.
Author Information
- Preeti Narayan1,*,
- Tatiana M. Prowell1,
- Jennifer J. Gao1,4,
- Laura L. Fernandes1,
- Emily Li2,
- Xiling Jiang1,
- Junshan Qiu1,
- Jianghong Fan1,
- Pengfei Song1,
- Jingyu Yu1,
- Xinyuan Zhang1,
- Bellinda L. King-Kallimanis1,
- Wei Chen1,
- Tiffany K. Ricks1,
- Yutao Gong1,
- Xing Wang1,
- Katherine Windsor1,
- Steve Y. Rhieu1,
- Gerlie Geiser1,
- Anamitro Banerjee1,
- Xiaohong Chen1,
- Francisca Reyes Turcu3,
- Deb K. Chatterjee3,
- Anand Pathak3,
- Jeffrey Seidman3,
- Soma Ghosh3,
- Reena Philip3,
- Kirsten B. Goldberg1,4,
- Paul G. Kluetz1,4,
- Shenghui Tang1,
- Laleh Amiri-Kordestani1,
- Marc R. Theoret1,4,
- Richard Pazdur1,4, and
- Julia A. Beaver1,4
- 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
- 2Oncology Center of Excellence Summer Scholars Program, Silver Spring, Maryland.
- 3Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
- 4Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
- ↵*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
April 2021
Volume 27, Issue 7
Volume 27, Issue 7
FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
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