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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: Alpelisib for PIK3CA-Related Overgrowth Spectrum

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 article titled, FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
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Includes: Supplementary data
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: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (3): 508–512.
https://doi.org/10.1158/1078-0432.CCR-22-2072
Published: 01 February 2023
View article titled, FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with <em>EGFR</em> Exon 20 Insertion Mutations
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Journal Articles

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer

Elizabeth S. Duke, Amy K. Barone, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Emasenyie Isikwei, Hong Zhao, Youwei Bi, Jiang Liu, Nam Atiqur Rahman, Emily Wearne, John K. Leighton, Maritsa Stephenson, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (19): 4173–4177.
https://doi.org/10.1158/1078-0432.CCR-22-0873
Published: 03 October 2022
View article titled, FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer
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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

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma

Erica C. Nakajima, Paz J. Vellanki, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Youwei Bi, Hisham Qosa, Jiang Liu, Hong Zhao, Missiratch Biable, Lauren Tesh Hotaki, Yuan-Li Shen, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (3): 446–451.
https://doi.org/10.1158/1078-0432.CCR-21-1466
Published: 01 February 2022
View article titled, FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma
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Journal Articles

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Abigail L. Koch, Paz J. Vellanki, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan Li Shen, Huiming Xia, Yangbing Li, Jiang Liu, Jeanne Fourie Zirkelbach, Elitza Palazov, Aleksandr Gamarian, Qiuyi Choo, Arūnas Girčys, Ulrich-Peter Rohr, Nataliya Fesenko, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (24): 6638–6643.
https://doi.org/10.1158/1078-0432.CCR-21-1034
Published: 15 December 2021
View article titled, FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review
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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: Selumetinib for Plexiform Neurofibroma

Denise Casey, Suzanne Demko, Arup Sinha, Pallavi S. Mishra-Kalyani, Yuan-li Shen, Sachia Khasar, M. Anwar Goheer, Whitney S. Helms, Lili Pan, Yuan Xu, Jianghong Fan, Ruby Leong, Jiang Liu, Yuching Yang, Katherine Windsor, Mei Ou, Olen Stephens, Byeongtaek Oh, Gregory H. Reaman, Abhilasha Nair, Stacy S. Shord, Vishal Bhatnagar, Selena R. Daniels, Sharon Sickafuse, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (15): 4142–4146.
https://doi.org/10.1158/1078-0432.CCR-20-5032
Published: 01 August 2021
View article titled, FDA Approval Summary: Selumetinib for Plexiform Neurofibroma
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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

FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Emily Y. Jen, Xin Gao, Liang Li, Luning Zhuang, Natalie E. Simpson, Baikuntha Aryal, Rong Wang, Donna Przepiorka, Yuan Li Shen, Ruby Leong, Chao Liu, Christopher M. Sheth, Steven Bowen, Kirsten B. Goldberg, Ann T. Farrell, Gideon M. Blumenthal, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (3): 532–536.
https://doi.org/10.1158/1078-0432.CCR-19-2329
Published: 03 February 2020
View article titled, FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia

Kelly J. Norsworthy, Kunthel By, Sriram Subramaniam, Luning Zhuang, Pedro L. Del Valle, Donna Przepiorka, Yuan-Li Shen, Christopher M. Sheth, Chao Liu, Ruby Leong, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (20): 6021–6025.
https://doi.org/10.1158/1078-0432.CCR-19-0365
Published: 15 October 2019
View article titled, FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation

Kelly J. Norsworthy, Lola Luo, Vicky Hsu, Ramadevi Gudi, Sarah E. Dorff, Donna Przepiorka, Albert Deisseroth, Yuan-Li Shen, Christopher M. Sheth, Rosane Charlab, Gene M. Williams, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (11): 3205–3209.
https://doi.org/10.1158/1078-0432.CCR-18-3749
Published: 03 June 2019
View article titled, FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia

Aviva C. Krauss, Xin Gao, Liang Li, Michael L. Manning, Paresma Patel, Wentao Fu, Kumar G. Janoria, Gerlie Gieser, David A. Bateman, Donna Przepiorka, Yuan Li Shen, Stacy S. Shord, Christopher M. Sheth, Anamitro Banerjee, Jiang Liu, Kirsten B. Goldberg, Ann T. Farrell, Gideon M. Blumenthal, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (9): 2685–2690.
https://doi.org/10.1158/1078-0432.CCR-18-2990
Published: 01 May 2019
View article titled, FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia
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Includes: Supplementary data
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: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Hyon-Zu Lee, Virginia E. Kwitkowski, Pedro L. Del Valle, M. Stacey Ricci, Haleh Saber, Bahru A. Habtemariam, Julie Bullock, Erik Bloomquist, Yuan Li Shen, Xiao-Hong Chen, Janice Brown, Nitin Mehrotra, Sarah Dorff, Rosane Charlab, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (12): 2666–2670.
https://doi.org/10.1158/1078-0432.CCR-14-3119
Published: 14 June 2015
View article titled, FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
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Journal Articles

Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer

Vinni Juneja, Patricia Keegan, Joseph E. Gootenberg, Mark D. Rothmann, Yuan Li Shen, Kyung Y. Lee, Karen D. Weiss, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2008) 14 (11): 3242–3247.
https://doi.org/10.1158/1078-0432.CCR-07-1872
Published: 02 June 2008
View article titled, Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents in Patients with Cancer
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