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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: 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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Journal Articles

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

Christy L. Osgood, Meredith K. Chuk, Marc R. Theoret, Lan Huang, Kun He, Leah Her, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (21): 6384–6389.
https://doi.org/10.1158/1078-0432.CCR-16-2422
Published: 31 October 2017
View article titled, FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen
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Journal Articles

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Amy Barone, Maitreyee Hazarika, Marc R. Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5661–5665.
https://doi.org/10.1158/1078-0432.CCR-16-0664
Published: 01 October 2017
View article titled, FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma
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Journal Articles

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

Meredith K. Chuk, Jennie T. Chang, Marc R. Theoret, Emmanuel Sampene, Kun He, Shawna L. Weis, Whitney S. Helms, Runyan Jin, Hongshan Li, Jingyu Yu, Hong Zhao, Liang Zhao, Mark Paciga, Deborah Schmiel, Rashmi Rawat, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5666–5670.
https://doi.org/10.1158/1078-0432.CCR-16-0663
Published: 01 October 2017
View article titled, FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma
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Journal Articles

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma

Julia A. Beaver, Marc R. Theoret, Sirisha Mushti, Kun He, Meredith Libeg, Kirsten Goldberg, Rajeshwari Sridhara, Amy E. McKee, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3479–3483.
https://doi.org/10.1158/1078-0432.CCR-16-0714
Published: 13 July 2017
View article titled, FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAF<sup>V600</sup> Wild-Type Unresectable or Metastatic Melanoma
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Journal Articles

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

Maitreyee Hazarika, Meredith K. Chuk, Marc R. Theoret, Sirisha Mushti, Kun He, Shawna L. Weis, Alexander H. Putman, Whitney S. Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3484–3488.
https://doi.org/10.1158/1078-0432.CCR-16-0712
Published: 13 July 2017
View article titled, U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
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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 Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Denise Casey, Suzanne Demko, Stacy Shord, Hong Zhao, Huanyu Chen, Kun He, Alexander Putman, Whitney Helms, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (10): 2377–2381.
https://doi.org/10.1158/1078-0432.CCR-16-2051
Published: 14 May 2017
View article titled, FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma
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Journal Articles

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

Sean Khozin, Chana Weinstock, Gideon M. Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab, Ingrid Fan, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (9): 2131–2135.
https://doi.org/10.1158/1078-0432.CCR-16-1773
Published: 30 April 2017
View article titled, Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer
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Journal Articles

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib

Erin Larkins, Gideon M. Blumenthal, Huanyu Chen, Kun He, Rajiv Agarwal, Gerlie Gieser, Olen Stephens, Eias Zahalka, Kimberly Ringgold, Whitney Helms, Stacy Shord, Jingyu Yu, Hong Zhao, Gina Davis, Amy E. McKee, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (21): 5171–5176.
https://doi.org/10.1158/1078-0432.CCR-16-1293
Published: 31 October 2016
View article titled, FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib
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Journal Articles

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study

Kun He, Huanyu Chen, Thomas Gwise, Sandra Casak, Steven Lemery, Patricia Keegan, Richard Pazdur, Rajeshwari Sridhara
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (21): 5167–5170.
https://doi.org/10.1158/1078-0432.CCR-16-1010
Published: 31 October 2016
View article titled, Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study
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Journal Articles

FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation–Positive Non–Small Cell Lung Cancer

Dickran Kazandjian, Gideon M. Blumenthal, Weishi Yuan, Kun He, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (6): 1307–1312.
https://doi.org/10.1158/1078-0432.CCR-15-2266
Published: 14 March 2016
View article titled, FDA Approval of Gefitinib for the Treatment of Patients with Metastatic <em>EGFR</em> Mutation–Positive Non–Small Cell Lung Cancer
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Journal Articles

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer

Abhilasha Nair, Steven J. Lemery, Jun Yang, Anshu Marathe, Liang Zhao, Hong Zhao, Xiaoping Jiang, Kun He, Gaetan Ladouceur, Amit K. Mitra, Liang Zhou, Emily Fox, Stephanie Aungst, Whitney Helms, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (23): 5205–5208.
https://doi.org/10.1158/1078-0432.CCR-15-1377
Published: 30 November 2015
View article titled, FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer
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Journal Articles

FDA Approval Summary: Ramucirumab for Gastric Cancer

Sandra J. Casak, Ibilola Fashoyin-Aje, Steven J. Lemery, Lillian Zhang, Runyan Jin, Hongshan Li, Liang Zhao, Hong Zhao, Hui Zhang, Huanyu Chen, Kun He, Michele Dougherty, Rachel Novak, Sarah Kennett, Sachia Khasar, Whitney Helms, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (15): 3372–3376.
https://doi.org/10.1158/1078-0432.CCR-15-0600
Published: 02 August 2015
View article titled, FDA Approval Summary: Ramucirumab for Gastric Cancer
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Journal Articles

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Geoffrey Kim, Amy E. McKee, Yang-Min Ning, Maitreyee Hazarika, Marc Theoret, John R. Johnson, Qiang Casey Xu, Shenghui Tang, Rajeshwari Sridhara, Xiaoping Jiang, Kun He, Donna Roscoe, W. David McGuinn, Whitney S. Helms, Anne Marie Russell, Sarah Pope Miksinski, Jeanne Fourie Zirkelbach, Justin Earp, Qi Liu, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (19): 4994–5000.
https://doi.org/10.1158/1078-0432.CCR-14-0776
Published: 30 September 2014
View article titled, FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAF<sup>V600E</sup> Mutation
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Journal Articles

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

Michael Axelson, Ke Liu, Xiaoping Jiang, Kun He, Jian Wang, Hong Zhao, Dubravka Kufrin, Todd Palmby, Zedong Dong, Anne Marie Russell, Sarah Miksinski, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (9): 2289–2293.
https://doi.org/10.1158/1078-0432.CCR-12-1956
Published: 30 April 2013
View article titled, U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma
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Journal Articles

Overestimation of the Effect Size in Group Sequential Trials

Jenny J. Zhang, Gideon M. Blumenthal, Kun He, Shenghui Tang, Patricia Cortazar, Rajeshwari Sridhara
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (18): 4872–4876.
https://doi.org/10.1158/1078-0432.CCR-11-3118
Published: 16 September 2012
View article titled, Overestimation of the Effect Size in Group Sequential Trials
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Journal Articles

Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial

Martha Donoghue, Steven J. Lemery, Weishi Yuan, Kun He, Rajeshwari Sridhara, Stacy Shord, Hong Zhao, Anshu Marathe, Lori Kotch, Josephine Jee, Ying Wang, Liang Zhou, William M. Adams, Vaishali Jarral, Anne Pilaro, Richard Lostritto, Joseph E. Gootenberg, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (6): 1496–1505.
https://doi.org/10.1158/1078-0432.CCR-11-2149
Published: 14 March 2012
View article titled, Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial
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Journal Articles

Vorinostat for Treatment of Cutaneous Manifestations of Advanced Primary Cutaneous T-Cell Lymphoma

Bhupinder S. Mann, John R. Johnson, Kun He, Rajeshwari Sridhara, Sophia Abraham, Brian P. Booth, Leigh Verbois, David E. Morse, Josephine M. Jee, Sarah Pope, Ravi S. Harapanhalli, Ramzi Dagher, Ann Farrell, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2007) 13 (8): 2318–2322.
https://doi.org/10.1158/1078-0432.CCR-06-2672
Published: 16 April 2007
View article titled, Vorinostat for Treatment of Cutaneous Manifestations of Advanced Primary Cutaneous T-Cell Lymphoma
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