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Lola A. Fashoyin-Aje
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Journal Articles

FDA Approval Summary: Idecabtagene Vicleucel for the Treatment of Triple-Class–Exposed, Relapsed or Refractory Multiple Myeloma

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Poornima Sharma, Xue Lin, Zhenzhen Xu, Bindu Kanapuru, Marc R. Theoret, Robert Sokolic, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF6.
https://doi.org/10.1158/1078-0432.CCR-24-4181
Published: 01 July 2025
View articletitled, FDA Approval Summary: Idecabtagene Vicleucel for the Treatment of Triple-Class–Exposed, Relapsed or Refractory Multiple Myeloma
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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

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: 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

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

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: 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
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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

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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

Driving Diversity and Inclusion in Cancer Drug Development – Industry and Regulatory Perspectives, Current Practices, Opportunities, and Challenges

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Lola A. Fashoyin-Aje, Craig Tendler, Bea Lavery, Serban Ghiorghiu, Brittany Gerald, Chitkala Kalidas, Nicole Richie, Kathleen Winson, Nicholas J.H. Warren, Tristen V. Tellman, Jon Retzlaff, Margaret Foti, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (18): 3566–3572.
https://doi.org/10.1158/1078-0432.CCR-23-1391
Published: 15 September 2023
View articletitled, Driving Diversity and Inclusion in Cancer Drug Development – Industry and Regulatory Perspectives, Current Practices, Opportunities, and Challenges
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor

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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 articletitled, 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

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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 articletitled, 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

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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 articletitled, 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

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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 articletitled, 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

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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 articletitled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
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Journal Articles

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

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