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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: 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: 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

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 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

Assessment of Audit Methodologies for Bias Evaluation of Tumor Progression in Oncology Clinical Trials

Jenny J. Zhang, Lijun Zhang, Huanyu Chen, Anthony J. Murgo, Lori E. Dodd, Richard Pazdur, Rajeshwari Sridhara
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (10): 2637–2645.
https://doi.org/10.1158/1078-0432.CCR-12-3364
Published: 12 May 2013
View article titled, Assessment of Audit Methodologies for Bias Evaluation of Tumor Progression in Oncology Clinical Trials
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