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Paul G. Kluetz
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Journal Articles

FDA Approval Summary: Abatacept for the Prophylaxis of Acute GVHD

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Kelly J. Norsworthy, Donna R. Rivera, Joseph Wynne, Jian Zhao, Robyn Konicki, Aida Kuzucan, Jonathon Vallejo, Ruby Leong, Olanrewaju O. Okusanya, Brian Booth, Paul G. Kluetz, Richard Pazdur, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-25-0688
Published: 10 June 2025
View articletitled, FDA Approval Summary: Abatacept for the Prophylaxis of Acute GVHD
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Afamitresgene Autoleucel for Adults with HLA-Restricted, MAGE-A4–Positive Unresectable or Metastatic Synovial Sarcoma after Prior Chemotherapy

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Katherine K. Barnett, Abigail R. Johnson, Asha Das, Ching-Hsien J. Lee, Cong Wang, Xiaofei Wang, Elin S. Cho, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-25-0595
Published: 10 June 2025
View articletitled, FDA Approval Summary: Afamitresgene Autoleucel for Adults with HLA-Restricted, MAGE-A4–Positive Unresectable or Metastatic Synovial Sarcoma after Prior Chemotherapy
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Journal Articles

Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19

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Timil H. Patel, Amy Corneli, Pamela Balcazar, Craig Lipset, Sara B. Calvert, Sabrena Mervin-Blake, Vinit Nalawade, Paul G. Kluetz
Journal: Clinical Cancer Research
Clin Cancer Res (2025) 31 (10): 1827–1830.
https://doi.org/10.1158/1078-0432.CCR-24-3357
Published: 15 May 2025
View articletitled, Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Nadofaragene Firadenovec-vncg for Bacillus Calmette–Guérin–Unresponsive Non–Muscle-Invasive Bladder Cancer

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Laronna Colbert, Yuxia Jia, Anurag Sharma, Jiang Hu, Zhenzhen Xu, Daniel L. Suzman, Asha Das, Peter Bross, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2025) 31 (7): 1182–1185.
https://doi.org/10.1158/1078-0432.CCR-24-2812
Published: 01 April 2025
View articletitled, FDA Approval Summary: Nadofaragene Firadenovec-vncg for Bacillus Calmette–Guérin–Unresponsive Non–Muscle-Invasive Bladder Cancer
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Journal Articles

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

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Sundeep Agrawal, Clara Lee, William F. Pierce, Elizabeth Everhart, Adriene King-Ducre, Melanie Royce, Christy L. Osgood, Laleh Amiri-Kordestani, Haw-Jyh Chiu, Tiffany K. Ricks, Lili Pan, Jeanne Fourie Zirkelbach, Rosane Charlab, Michael Pacanowski, Tamy Kim, Richard Pazdur, Paul G. Kluetz, Jennifer J. Gao
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (24): 5508–5514.
https://doi.org/10.1158/1078-0432.CCR-24-1708
Published: 16 December 2024
View articletitled, FDA Approval Summary: Capecitabine Labeling Update under Project Renewal
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Journal Articles

FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma

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Jaleh Fallah, Brian L. Heiss, Hee-Koung Joeng, Chana Weinstock, Xin Gao, William F. Pierce, Benjamin Chukwurah, Vishal Bhatnagar, Mallorie H. Fiero, Laleh Amiri-Kordestani, Richard Pazdur, Paul G. Kluetz, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (22): 5003–5008.
https://doi.org/10.1158/1078-0432.CCR-24-1199
Published: 15 November 2024
View articletitled, FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

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Michael H. Brave, William F. Maguire, Chana Weinstock, Hui Zhang, Xin Gao, Fang Li, Jingyu Yu, Wentao Fu, Hong Zhao, William F. Pierce, Elaine Chang, Jeannette Dinin, Mallorie H. Fiero, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (21): 4815–4821.
https://doi.org/10.1158/1078-0432.CCR-24-1393
Published: 01 November 2024
View articletitled, FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer

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Michael I. Barbato, Diana Bradford, Yi Ren, Stephanie L. Aungst, Claudia P. Miller, Lili Pan, Jeanne F. Zirkelbach, Yangbing Li, Youwei Bi, Jianghong Fan, Manuela Grimstein, Sarah E. Dorff, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Peter Schotland, Opeyemi Udoka, Idara Ojofeitimi, John K. Leighton, Nam A. Rahman, Richard Pazdur, Harpreet Singh, Paul G. Kluetz, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (16): 3364–3370.
https://doi.org/10.1158/1078-0432.CCR-24-0949
Published: 15 August 2024
View articletitled, FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
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Journal Articles

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

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

A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma

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Elaine Chang, Jiaxi Zhou, Chi Song, Haley Gittleman, Laura Fernandes, Chana Weinstock, Michael B. Atkins, Sundeep Agrawal, Rajeshwari Sridhara, Nicole Gormley, Shenghui Tang, Daniel L. Suzman, Laleh Amiri-Kordestani, Paul G. Kluetz, Richard Pazdur, Brian I. Rini, David F. McDermott, Meredith M. Regan
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (15): 3282–3286.
https://doi.org/10.1158/1078-0432.CCR-23-3719
Published: 01 August 2024
View articletitled, A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma
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Includes: Supplementary data
Journal Articles

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

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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 articletitled, FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
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Journal Articles

Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium

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Jason Fangusaro, Robert A. Avery, Michael J. Fisher, Roger J. Packer, Karin S. Walsh, Antoinette Schouten-van Meeteren, Dominik Karres, Diana Bradford, Vishal Bhatnagar, Harpreet Singh, Paul G. Kluetz, Martha Donoghue, Elizabeth S. Duke
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (11): 2303–2308.
https://doi.org/10.1158/1078-0432.CCR-23-3386
Published: 03 June 2024
View articletitled, Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium
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Journal Articles

FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

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William F. Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C. Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S. Hamed, Erik W. Bloomquist, Shenghui Tang, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (10): 2011–2016.
https://doi.org/10.1158/1078-0432.CCR-23-3738
Published: 15 May 2024
View articletitled, FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
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Includes: Supplementary data
Journal Articles

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

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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 articletitled, 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: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma

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Michael I. Barbato, Jeannette Nashed, Diana Bradford, Yi Ren, Sachia Khasar, Claudia P. Miller, Banu S. Zolnik, Hong Zhao, Yangbing Li, Youwei Bi, Stacy S. Shord, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Raniya A. Al-Matari, Richard Pazdur, Paul G. Kluetz, Martha Donoghue, Harpreet Singh, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (2): 263–268.
https://doi.org/10.1158/1078-0432.CCR-23-1503
Published: 17 January 2024
View articletitled, FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma
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Journal Articles

FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

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Sonia Singh, Diana Bradford, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Lingshan Wang, Hong Zhao, Ye Xiong, Jiang Liu, Rosane Charlab, Jeffrey Kraft, Sachia Khasar, Claudia P. Miller, Donna R. Rivera, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (1): 23–28.
https://doi.org/10.1158/1078-0432.CCR-23-1270
Published: 05 January 2024
View articletitled, FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

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Jennifer J. Gao, Christy L. Osgood, Zhou Feng, Erik W. Bloomquist, Shenghui Tang, C.J. George Chang, Tiffany K. Ricks, Sherry C. Hou, William F. Pierce, Donna R. Rivera, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (24): 5008–5011.
https://doi.org/10.1158/1078-0432.CCR-23-1133
Published: 15 December 2023
View articletitled, FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
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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

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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 articletitled, FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer
Open the PDF for FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer in another window
Journal Articles

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

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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 articletitled, 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: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer

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Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H. Fiero, Ankit Shah, Salaheldin S. Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K. Ricks, Rajan Pragani, Arulvathani Arudchandran, Paresma Patel, Shadia Zaman, Arpita Roy, Shyam Kalavar, Soma Ghosh, William F. Pierce, Nam Atiqur Rahman, Shenghui Tang, Bronwyn D. Mixter, Paul G. Kluetz, Richard Pazdur, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (19): 3835–3840.
https://doi.org/10.1158/1078-0432.CCR-23-0991
Published: 02 October 2023
View articletitled, FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer
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