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Journal Articles

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

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

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 article titled, FDA Approval Summary: Dabrafenib in Combination with Trametinib for <em>BRAF</em><sup>V600E</sup> Mutation–Positive Low-Grade Glioma
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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: 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: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Katie Chon, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Stephanie Aungst, Emily Wearne, Sriram Subramaniam, Yangbing Li, Jiang Liu, Jielin Sun, Rosane Charlab, Hong Zhao, Banu Saritas-Yildirim, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (17): 3262–3266.
https://doi.org/10.1158/1078-0432.CCR-22-3713
Published: 01 September 2023
View article titled, FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with <em>EGFR</em> Exon 20 Insertion Mutations
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Includes: Supplementary data
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: 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

Serum Concentration of CD137 and Tumor Infiltration by M1 Macrophages Predict the Response to Sintilimab plus Bevacizumab Biosimilar in Advanced Hepatocellular Carcinoma Patients

Wen Zhang, Caifeng Gong, Xuenan Peng, Xinyu Bi, Yongkun Sun, Jianguo Zhou, Fan Wu, Huiying Zeng, Yan Wang, Hui Zhou, Hong Zhao, Jianqiang Cai, Aiping Zhou
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (16): 3499–3508.
https://doi.org/10.1158/1078-0432.CCR-21-3972
Published: 15 August 2022
View article titled, Serum Concentration of CD137 and Tumor Infiltration by M1 Macrophages Predict the Response to Sintilimab plus Bevacizumab Biosimilar in Advanced Hepatocellular Carcinoma Patients
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC

Oladimeji Akinboro, Erin Larkins, Lee H. Pai-Scherf, Luckson N. Mathieu, Yi Ren, Joyce Cheng, Mallorie H. Fiero, Wentao Fu, Youwei Bi, Shyam Kalavar, Samina Jafri, Pallavi S. Mishra-Kalyani, Jeanne Fourie Zirkelbach, Hongshan Li, Hong Zhao, Kun He, Whitney S. Helms, Meredith K. Chuk, Min Wang, Ilynn Bulatao, Jonathan Herz, Blaire L. Osborn, Yuan Xu, Jiang Liu, Yutao Gong, Sharon Sickafuse, Rebecca Cohen, Martha Donoghue, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (11): 2221–2228.
https://doi.org/10.1158/1078-0432.CCR-21-3844
Published: 01 June 2022
View article titled, FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
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Journal Articles

FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC

Erica C. Nakajima, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yajun Liu, Hong Zhao, Youwei Bi, Jiang Liu, Atiqur Rahman, Emily Wearne, Idara Ojofeitimi, Lauren Tesh Hotaki, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (8): 1482–1486.
https://doi.org/10.1158/1078-0432.CCR-21-3074
Published: 14 April 2022
View article titled, FDA Approval Summary: Sotorasib for <em>KRAS G12C</em>-Mutated Metastatic NSCLC
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Journal Articles

A Novel Third-generation EGFR Tyrosine Kinase Inhibitor Abivertinib for EGFR T790M-mutant Non–Small Cell Lung Cancer: a Multicenter Phase I/II Study

Qing Zhou, Lin Wu, Pei Hu, Tongtong An, Jianying Zhou, Li Zhang, Xiao-Qing Liu, Feng Luo, Xin Zheng, Ying Cheng, Nong Yang, Junling Li, Jifeng Feng, Baohui Han, Yong Song, Kai Wang, Li Zhang, Jian Fang, Hong Zhao, Yongqian Shu, Xiao-Yan Lin, Zhihong Chen, Bin Gan, Wan-Hong Xu, Wei Tang, Xiaoying Zhang, Jin-Ji Yang, Xiao Xu, Yi-Long Wu
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (6): 1127–1135.
https://doi.org/10.1158/1078-0432.CCR-21-2595
Published: 15 March 2022
View article titled, A Novel Third-generation EGFR Tyrosine Kinase Inhibitor Abivertinib for EGFR T790M-mutant Non–Small Cell Lung Cancer: a Multicenter Phase I/II Study
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Includes: Supplementary data
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: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Luckson N. Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup K. Amatya, Mallorie H. Fiero, Pallavi S. Mishra-Kalyani, Whitney S. Helms, Claire E. Myers, Amy M. Skinner, Stephanie Aungst, Runyan Jin, Hong Zhao, Huiming Xia, Jeanne Fourie Zirkelbach, Youwei Bi, Yangbing Li, Jiang Liu, Manuela Grimstein, Xinyuan Zhang, Stacie Woods, Kelie Reece, Abdelrahmman M. Abukhdeir, Soma Ghosh, Reena Philip, Shenghui Tang, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (2): 249–254.
https://doi.org/10.1158/1078-0432.CCR-21-1566
Published: 19 January 2022
View article titled, FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
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Journal Articles

FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Janice Kim, Diana Bradford, Erin Larkins, Lee H. Pai-Scherf, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Emily Wearne, Whitney S. Helms, Amal Ayyoub, Youwei Bi, Jielin Sun, Rosane Charlab, Jiang Liu, Hong Zhao, Dun Liang, Soma Ghosh, Reena Philip, Richard Pazdur, Marc R. Theoret, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (20): 5452–5456.
https://doi.org/10.1158/1078-0432.CCR-21-0967
Published: 15 October 2021
View article titled, FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With <em>RET</em> Gene Mutations or Fusions
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review

Paz J. Vellanki, Flora Mulkey, Adnan A. Jaigirdar, Lisa Rodriguez, Yibo Wang, Yuan Xu, Hong Zhao, Jiang Liu, Grant Howe, Jian Wang, Qiuyi Choo, Sarah J. Golding, Victoria Mansell, Kwadwo Korsah, Dianne Spillman, R. Angelo de Claro, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (13): 3522–3527.
https://doi.org/10.1158/1078-0432.CCR-20-4338
Published: 01 July 2021
View article titled, FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review
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Journal Articles

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2378–2382.
https://doi.org/10.1158/1078-0432.CCR-20-3901
Published: 01 May 2021
View article titled, FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
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Includes: Supplementary data
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: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

Leigh Marcus, Martha Donoghue, Stephanie Aungst, Claire E. Myers, Whitney S. Helms, Guoxiang Shen, Hong Zhao, Olen Stephens, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 928–932.
https://doi.org/10.1158/1078-0432.CCR-20-2771
Published: 15 February 2021
View article titled, FDA Approval Summary: Entrectinib for the Treatment of <em>NTRK</em> gene Fusion Solid Tumors
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Journal Articles

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

Amy Barone, Dow-Chung Chi, Marc R. Theoret, Huanyu Chen, Kun He, Dubravka Kufrin, Whitney S. Helms, Sriram Subramaniam, Hong Zhao, Anuja Patel, Kirsten B. Goldberg, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (24): 7448–7453.
https://doi.org/10.1158/1078-0432.CCR-17-0898
Published: 14 December 2017
View article titled, FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen
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