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Paul G. Kluetz
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Journal Articles

FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Sandra J. Casak, Shan Pradhan, Lola A. Fashoyin-Aje, Yi Ren, Yuan-Li Shen, Yuan Xu, Edwin Chiu Yuen Chow, Ye Xiong, Jeanne Fourie Zirklelbach, Jiang Liu, Rosane Charlab, William F. Pierce, Nataliya Fesenko, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF5.
DOI: https://doi.org/10.1158/1078-0432.CCR-21-4462
Published: 21 March 2022
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FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Elaine Chang, Chana Weinstock, Lijun Zhang, Mallorie H. Fiero, Miao Zhao, Eias Zahalka, Tiffany K. Ricks, Jeanne Fourie Zirkelbach, Junshan Qiu, Jingyu Yu, Xiao Hong Chen, Vishal Bhatnagar, Kirsten B. Goldberg, Shenghui Tang, Paul G. Kluetz, Richard Pazdur, Amna Ibrahim, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (3): 441–445.
DOI: https://doi.org/10.1158/1078-0432.CCR-21-2334
Published: 01 February 2022
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Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Anup K. Amatya, Mallorie H. Fiero, Erik W. Bloomquist, Arup K. Sinha, Steven J. Lemery, Harpreet Singh, Amna Ibrahim, Martha Donoghue, Lola A. Fashoyin-Aje, R. Angelo de Claro, Nicole J. Gormley, Laleh Amiri-Kordestani, Rajeshwari Sridhara, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Shenghui Tang
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (21): 5753–5756.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-4912
Published: 01 November 2021
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The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Julie A. Schneider, Yutao Gong, Kirsten B. Goldberg, Paul G. Kluetz, Marc R. Theoret, Laleh Amiri-Kordestani, Julia A. Beaver, Lola Fashoyin-Aje, Nicole J. Gormley, Adnan A. Jaigirdar, Steven J. Lemery, Pallavi S. Mishra-Kalyani, Gregory H. Reaman, Donna R. Rivera, Wendy S. Rubinstein, Harpreet Singh, Rajeshwari Sridhara, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (19): 5161–5167.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-4429
Published: 01 October 2021
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

Sandra J. Casak, Leigh Marcus, Lola Fashoyin-Aje, Sirisha L. Mushti, Joyce Cheng, Yuan-Li Shen, William F. Pierce, Leah Her, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (17): 4680–4684.
DOI: https://doi.org/10.1158/1078-0432.CCR-21-0557
Published: 01 September 2021
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Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group

Allison Magnuson, Suanna S. Bruinooge, Harpreet Singh, Keith D. Wilner, Shadia Jalal, Stuart M. Lichtman, Paul G. Kluetz, Gary H. Lyman, Heidi D. Klepin, Mark E. Fleury, Brad Hirsch, Allen Melemed, Fernanda I. Arnaldez, Upal Basu Roy, Caroline Schenkel, Shimere Sherwood, Elizabeth Garrett-Mayer
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2424–2429.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3868
Published: 01 May 2021
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FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Yutao Gong, Hui Zhang, Erik W. Bloomquist, Xiling Jiang, Junshan Qiu, Jingyu Yu, Pengfei Song, Nam Atiqur Rahman, Haw-Jyh Chiu, Tiffany K. Ricks, Fatima Rizvi, Sherry Hou, Willie Wilson, Abde M. Abukhdeir, Jeffrey Seidman, Soma Ghosh, Reena Philip, William F. Pierce, Vishal Bhatnagar, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2126–2129.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3474
Published: 15 April 2021
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FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Diana Bradford, Erin Larkins, Sirisha L. Mushti, Lisa Rodriguez, Amy M. Skinner, Whitney S. Helms, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Jiang Liu, Rosane Charlab, Francisca Reyes Turcu, Dun Liang, Soma Ghosh, Donna Roscoe, Reena Philip, Autumn Zack-Taylor, Shenghui Tang, Paul G. Kluetz, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2130–2135.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3558
Published: 15 April 2021
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Sandra J. Casak, Martha Donoghue, Lola Fashoyin-Aje, Xiaoping Jiang, Lisa Rodriguez, Yuan-Li Shen, Yuan Xu, Xiling Jiang, Jiang Liu, Hong Zhao, William F. Pierce, Shubhangi Mehta, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1836–1841.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
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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, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1842–1849.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3652
Published: 01 April 2021
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FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue, William F. Pierce, Stacy S. Shord, Jennifer J. Gao, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 916–921.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-3213
Published: 15 February 2021
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U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (1): 11–14.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-2220
Published: 04 January 2021
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An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer

Michael Brave, Chana Weinstock, Jamie R. Brewer, Dow-Chung Chi, Daniel L. Suzman, Joyce Cheng, Lijun Zhang, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (18): 4717–4722.
DOI: https://doi.org/10.1158/1078-0432.CCR-19-3835
Published: 15 September 2020
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Includes: Supplementary data
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Abstract S10-02: Using real-world data (RWD) from an integrated platform for rapid analysis of patients with cancer with and without COVID-19 across distinct health systems

Shirish M. Gadgeel, Michael A. Thompson, Monika A. Izano, Clara Hwang, Tom Mikkelsen, James L. Weese, Frank M. Wolf, Andrew Schrag, Sheetal Walters, Harpreet Singh, Jonathan Hirsch, Thomas D. Brown, Paul G. Kluetz
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (18_Supplement): S10-02.
DOI: https://doi.org/10.1158/1557-3265.COVID-19-S10-02
Published: 15 September 2020
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FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1

Preeti Narayan, Sakar Wahby, Jennifer J. Gao, Laleh Amiri-Kordestani, Amna Ibrahim, Erik Bloomquist, Shenghui Tang, Yuan Xu, Jiang Liu, Wentao Fu, Pengfei Song, Bellinda L. King-Kallimanis, Sherry Hou, Yutao Gong, Shyam Kalavar, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Marc R. Theoret, Gideon M. Blumenthal, Paul G. Kluetz, Rajeshwari Sridhara, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (10): 2284–2289.
DOI: https://doi.org/10.1158/1078-0432.CCR-19-3545
Published: 15 May 2020
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FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer

Lynn J. Howie, Nancy S. Scher, Laleh Amiri-Kordestani, Lijun Zhang, Bellinda L. King-Kallimanis, Yasmin Choudhry, Jason Schroeder, Kirsten B. Goldberg, Paul G. Kluetz, Amna Ibrahim, Rajeshwari Sridhara, Gideon M. Blumenthal, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (10): 2949–2955.
DOI: https://doi.org/10.1158/1078-0432.CCR-18-3003
Published: 15 May 2019
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Clinical Development of Novel Drug–Radiotherapy Combinations

Saif S. Ahmad, Marka R. Crittenden, Phuoc T. Tran, Paul G. Kluetz, Gideon M. Blumenthal, Helen Bulbeck, Richard D. Baird, Kaye J. Williams, Tim Illidge, Stephen M. Hahn, Theodore S. Lawrence, Patricia A. Spears, Amanda J. Walker, Ricky A. Sharma
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (5): 1455–1461.
DOI: https://doi.org/10.1158/1078-0432.CCR-18-2466
Published: 01 March 2019
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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, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (17): 4066–4071.
DOI: https://doi.org/10.1158/1078-0432.CCR-18-0042
Published: 04 September 2018
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U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Harpreet Singh, Amanda J. Walker, Laleh Amiri-Kordestani, Joyce Cheng, Shenghui Tang, Pamela Balcazar, Kimberly Barnett-Ringgold, Todd R. Palmby, Xianhua Cao, Nan Zheng, Qi Liu, Jingyu Yu, William F. Pierce, Selena R. Daniels, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (15): 3486–3491.
DOI: https://doi.org/10.1158/1078-0432.CCR-17-3628
Published: 31 July 2018
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Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections

Janice Kim, Harpreet Singh, Kassa Ayalew, Kristina Borror, Michelle Campbell, Laura Lee Johnson, Alyson Karesh, Ni A. Khin, Joanne R. Less, Jerry Menikoff, Lori Minasian, Sandra A. Mitchell, Elektra J. Papadopoulos, Richard L. Piekarz, Kevin A. Prohaska, Susan Thompson, Rajeshwari Sridhara, Richard Pazdur, Paul G. Kluetz
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (8): 1780–1784.
DOI: https://doi.org/10.1158/1078-0432.CCR-17-2555
Published: 12 April 2018
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