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Steven J. Lemery
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Journal Articles

FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer

Sandra J. Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan, Anup K. Amatya, Joyce Cheng, Pallavi S. Mishra-Kalyani, Shenghui Tang, Steven J. Lemery, Doris Auth, Gina Davis, Paul G. Kluetz, Richard Pazdur, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (16): 3371–3377.
https://doi.org/10.1158/1078-0432.CCR-24-0517
Published: 15 August 2024
View article titled, FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer
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Journal Articles

FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

Michael J. Fusco, Sandra J. Casak, Sirisha L. Mushti, Joyce Cheng, Brian J. Christmas, Matthew D. Thompson, Wentao Fu, Hezhen Wang, Miyoung Yoon, Yuching Yang, Jason N. Moore, Youwei Bi, Yang Nan, Craig E. Long, Doris Auth, Nam A. Rahman, Shenghui Tang, Richard Pazdur, Lola A. Fashoyin-Aje, Paul G. Kluetz, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (15): 3100–3104.
https://doi.org/10.1158/1078-0432.CCR-24-0281
Published: 01 August 2024
View article titled, FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
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Journal Articles

FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma

Timil H. Patel, Jamie R. Brewer, Jiaxin Fan, Joyce Cheng, Yuan-Li Shen, Yue Xiang, Hong Zhao, Steven J. Lemery, Richard Pazdur, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (2): 269–273.
https://doi.org/10.1158/1078-0432.CCR-23-2124
Published: 17 January 2024
View article titled, FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma
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Journal Articles

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer

Sandra J. Casak, M. Naomi Horiba, Mengdie Yuan, Joyce Cheng, Steven J. Lemery, Yuan Li Shen, Wentao Fu, Jason N. Moore, Yangbing Li, Youwei Bi, Doris Auth, Nataliya Fesenko, Paul G. Kluetz, Richard Pazdur, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (21): 4326–4330.
https://doi.org/10.1158/1078-0432.CCR-23-1041
Published: 01 November 2023
View article titled, FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, <em>HER2</em>-Positive <em>RAS</em> Wild-Type Colorectal Cancer
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Journal Articles

FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements

Shruti U. Gandhy, Sandra J. Casak, Sirisha L. Mushti, Joyce Cheng, Sriram Subramaniam, Hong Zhao, Miao Zhao, Youwei Bi, Guansheng Liu, Jianghong Fan, Oluseyi Adeniyi, Rosane Charlab, Dubravka Kufrin, Matthew D. Thompson, Kristin Jarrell, Doris Auth, Steven J. Lemery, Richard Pazdur, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (20): 4027–4031.
https://doi.org/10.1158/1078-0432.CCR-23-1042
Published: 13 October 2023
View article titled, FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
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Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (18): 3573–3578.
https://doi.org/10.1158/1078-0432.CCR-23-0459
Published: 15 September 2023
View article titled, FDA Approval Summary: Selpercatinib for the Treatment of Advanced <em>RET</em> Fusion-Positive Solid Tumors
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Journal Articles

FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor

Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L. Mushti, Rosane Charlab, Elizabeth I. Spehalski, Hong Zhao, Matthew D. Thompson, Shenghui Tang, Richard Pazdur, Steven J. Lemery, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (11): 2020–2024.
https://doi.org/10.1158/1078-0432.CCR-22-2400
Published: 01 June 2023
View article titled, FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

Timil H. Patel, Leigh Marcus, M. Naomi Horiba, Martha Donoghue, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Robert N. Schuck, Yangbing Li, Xinyuan Zhang, Jeanne Fourie Zirkelbach, Rosane Charlab, Jiang Liu, Yuching Yang, Steven J. Lemery, Richard Pazdur, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (5): 838–842.
https://doi.org/10.1158/1078-0432.CCR-22-2036
Published: 01 March 2023
View article titled, FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
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Journal Articles

FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease

M. Naomi Horiba, Sandra J. Casak, Pallavi S. Mishra-Kalyani, Pourab Roy, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (24): 5244–5248.
https://doi.org/10.1158/1078-0432.CCR-22-0617
Published: 15 December 2022
View article titled, FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease
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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 (2022) 28 (13): 2733–2737.
https://doi.org/10.1158/1078-0432.CCR-21-4462
Published: 01 July 2022
View article titled, FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation
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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

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.
https://doi.org/10.1158/1078-0432.CCR-21-0557
Published: 01 September 2021
View article titled, FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma
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Journal Articles

FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden–High Solid Tumors

Leigh Marcus, Lola A. Fashoyin-Aje, Martha Donoghue, Mengdie Yuan, Lisa Rodriguez, Pamela S. Gallagher, Reena Philip, Soma Ghosh, Marc R. Theoret, Julia A. Beaver, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (17): 4685–4689.
https://doi.org/10.1158/1078-0432.CCR-21-0327
Published: 01 September 2021
View article titled, FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden–High Solid Tumors
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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.
https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
View article titled, FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
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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

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

Leigh Marcus, Steven J. Lemery, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (13): 3753–3758.
https://doi.org/10.1158/1078-0432.CCR-18-4070
Published: 01 July 2019
View article titled, FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors
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Journal Articles

FDA's Approval of the First Biosimilar to Bevacizumab

Sandra J. Casak, Steven J. Lemery, Jee Chung, Chana Fuchs, Sarah J. Schrieber, Edwin C.Y. Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne Rowzee, Sue Lim, Patricia Keegan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (18): 4365–4370.
https://doi.org/10.1158/1078-0432.CCR-18-0566
Published: 14 September 2018
View article titled, FDA's Approval of the First Biosimilar to Bevacizumab
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Journal Articles

FDA Approval Summary: TAS-102

Leigh Marcus, Steven J. Lemery, Sachia Khasar, Emily Wearne, Whitney S. Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (12): 2924–2927.
https://doi.org/10.1158/1078-0432.CCR-16-2157
Published: 14 June 2017
View article titled, FDA Approval Summary: TAS-102
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Journal Articles

FDA's Approach to Regulating Biosimilars

Steven J. Lemery, M. Stacey Ricci, Patricia Keegan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (8): 1882–1885.
https://doi.org/10.1158/1078-0432.CCR-16-1354
Published: 13 April 2017
View article titled, FDA's Approach to Regulating Biosimilars
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