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Journal Articles

FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data

Julie A. Schneider, Julia Eckstein, Kirsten B. Goldberg, Mark C. Ascione, Thamar Bailey, Kimberly Taylor, Aisha M. Coffey, Darshini Satchi, Howard Philips, Rajeshwari Sridhara, Abhilasha Nair, Richard Pazdur, Marc R. Theoret
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (16): 2964–2972.
https://doi.org/10.1158/1078-0432.CCR-22-3240
Published: 15 August 2023
View article titled, FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
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Includes: Supplementary data
Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-20-4912
Published: 01 November 2021
View article titled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-20-4429
Published: 01 October 2021
View article titled, The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
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Includes: Supplementary data
Journal Articles

Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop

Kristen L. Mueller, Marc R. Theoret, Steven J. Lemery, Laleh Amiri-Kordestani, Charlotte E. Ariyan, Michael B. Atkins, Donald A. Berry, Christian U. Blank, Angela M. DeMichele, Patrick M. Forde, Nageatte Ibrahim, Patricia Keegan, Tara C. Mitchell, Rebecca A. Moss, Caroline Robert, Rajeshwari Sridhara, Janis M. Taube, Michael T. Tetzlaff, Jennifer A. Wargo, Keith T. Flaherty, Michael J. Kaplan, Suzanne L. Topalian, Ashley F. Ward, Marc S. Hurlbert
Journal: Clinical Cancer Research
Series: Author Choice
Clin Cancer Res (2021) 27 (2): 394–401.
https://doi.org/10.1158/1078-0432.CCR-20-3285
Published: 19 January 2021
View article titled, Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop
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Journal Articles

Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies

Jamie R. Brewer, Elaine Chang, Sundeep Agrawal, Harpreet Singh, Daniel L. Suzman, James Xu, Chana Weinstock, Laura L. Fernandes, Joyce Cheng, Lijun Zhang, Diqiong Xie, Kirsten B. Goldberg, Erik W. Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Marc R. Theoret, Richard Pazdur, Amna Ibrahim, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (24): 6406–6411.
https://doi.org/10.1158/1078-0432.CCR-19-4229
Published: 15 December 2020
View article titled, Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies
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Journal Articles

FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis

Shaily Arora, Sanjeeve Balasubramaniam, Wei Zhang, Lijun Zhang, Rajeshwari Sridhara, Dianne Spillman, Jaigi P. Mathai, Bradley Scott, Sarah J. Golding, Michael Coory, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (19): 5062–5067.
https://doi.org/10.1158/1078-0432.CCR-19-3979
Published: 01 October 2020
View article titled, FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-19-3835
Published: 15 September 2020
View article titled, An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer

Suparna Wedam, Lola Fashoyin-Aje, Xin Gao, Erik Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Kirsten B. Goldberg, Bellinda L. King-Kallimanis, Marc R. Theoret, Amna Ibrahim, Laleh Amiri-Kordestani, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (16): 4180–4185.
https://doi.org/10.1158/1078-0432.CCR-19-3980
Published: 14 August 2020
View article titled, FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer
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Journal Articles

Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Kelly J. Norsworthy, Flora Mulkey, Emma C. Scott, Ashley F. Ward, Donna Przepiorka, Rosane Charlab, Sarah E. Dorff, Albert Deisseroth, Dickran Kazandjian, Rajeshwari Sridhara, Julia A. Beaver, Ann T. Farrell, R. Angelo de Claro, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (16): 4280–4288.
https://doi.org/10.1158/1078-0432.CCR-20-0834
Published: 14 August 2020
View article titled, Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis
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Includes: Supplementary data
Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-19-3545
Published: 15 May 2020
View article titled, FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1
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Journal Articles

FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer

Suparna Wedam, Lola Fashoyin-Aje, Erik Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Kirsten B. Goldberg, Marc R. Theoret, Laleh Amiri-Kordestani, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (6): 1208–1212.
https://doi.org/10.1158/1078-0432.CCR-19-2580
Published: 13 March 2020
View article titled, FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-18-3003
Published: 15 May 2019
View article titled, FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer
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Journal Articles

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease

Emily Y. Jen, Qing Xu, Aaron Schetter, Donna Przepiorka, Yuan Li Shen, Donna Roscoe, Rajeshwari Sridhara, Albert Deisseroth, Reena Philip, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (2): 473–477.
https://doi.org/10.1158/1078-0432.CCR-18-2337
Published: 15 January 2019
View article titled, FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease
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Includes: Supplementary data
Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-18-0042
Published: 04 September 2018
View article titled, FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-17-3628
Published: 31 July 2018
View article titled, U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
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Journal Articles

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Anand Shah, Erik Bloomquist, Shenghui Tang, Wentao Fu, Youwei Bi, Qi Liu, Jingyu Yu, Ping Zhao, Todd R. Palmby, Kirsten B. Goldberg, C.J. George Chang, Paresma Patel, Elleni Alebachew, Amy Tilley, William F. Pierce, Amna Ibrahim, Gideon M. Blumenthal, Rajeshwari Sridhara, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (13): 2999–3004.
https://doi.org/10.1158/1078-0432.CCR-17-2369
Published: 01 July 2018
View article titled, FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
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Journal Articles

Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies

Xin Gao, Lijun Zhang, Rajeshwari Sridhara
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (10): 2262–2267.
https://doi.org/10.1158/1078-0432.CCR-17-2111
Published: 14 May 2018
View article titled, Exploration of a Novel Intermediate Response Endpoint in Immunotherapy Clinical Studies
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Includes: Supplementary data
Journal Articles

Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials

Sirisha L. Mushti, Flora Mulkey, Rajeshwari Sridhara
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (10): 2268–2275.
https://doi.org/10.1158/1078-0432.CCR-17-1902
Published: 14 May 2018
View article titled, Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-17-2555
Published: 12 April 2018
View article titled, Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections
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Journal Articles

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation–Associated Advanced Ovarian Cancer

Sanjeeve Balasubramaniam, Julia A. Beaver, Sara Horton, Laura L. Fernandes, Shenghui Tang, Hisani N. Horne, Jinzhong Liu, Chao Liu, Sarah J. Schrieber, Jingyu Yu, Pengfei Song, William Pierce, Kim J. Robertson, Todd R. Palmby, Haw-Jyh Chiu, Eunice Y. Lee, Reena Philip, Robert Schuck, Rosane Charlab, Anamitro Banerjee, Xiao Hong Chen, Xing Wang, Kirsten B. Goldberg, Rajeshwari Sridhara, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (23): 7165–7170.
https://doi.org/10.1158/1078-0432.CCR-17-1337
Published: 30 November 2017
View article titled, FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <em>BRCA</em> Mutation–Associated Advanced Ovarian Cancer
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