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Journal Articles

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs

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Gwynn Ison, Julia A. Beaver, W. David McGuinn, Jr, Todd R. Palmby, Jeannette Dinin, Rosane Charlab, Anshu Marathe, Runyan Jin, Qi Liu, Xiao Hong Chen, Xavier Ysern, Olen Stephens, Ge Bai, Yaning Wang, Sarah E. Dorff, Joyce Cheng, Shenghui Tang, Rajeshwari Sridhara, William Pierce, Amy E. McKee, Amna Ibrahim, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (18): 4545–4549.
https://doi.org/10.1158/1078-0432.CCR-16-0638
Published: 15 September 2016
View articletitled, FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs
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Journal Articles

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

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

U.S. Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non–Small Cell Lung Cancer That Is Anaplastic Lymphoma Kinase Positive

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Shakun M. Malik, Virginia Ellen Maher, Karen E. Bijwaard, Robert L. Becker, Lijun Zhang, Shenghui W. Tang, Pengfei Song, Qi Liu, Anshu Marathe, Brenda Gehrke, Whitney Helms, Diane Hanner, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (8): 2029–2034.
https://doi.org/10.1158/1078-0432.CCR-13-3077
Published: 15 April 2014
View articletitled, U.S. Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non–Small Cell Lung Cancer That Is Anaplastic Lymphoma Kinase Positive
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Journal Articles

Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary

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Katherine Thornton, Geoffrey Kim, V. Ellen Maher, Somesh Chattopadhyay, Shenghui Tang, Young Jin Moon, Pengfei Song, Anshu Marathe, Suchitra Balakrishnan, Hao Zhu, Christine Garnett, Qi Liu, Brian Booth, Brenda Gehrke, Robert Dorsam, Leigh Verbois, Debasis Ghosh, Wendy Wilson, John Duan, Haripada Sarker, Sarah Pope Miksinski, Lisa Skarupa, Amna Ibrahim, Robert Justice, Anthony Murgo, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (14): 3722–3730.
https://doi.org/10.1158/1078-0432.CCR-12-0411
Published: 15 July 2012
View articletitled, Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary
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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

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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 articletitled, 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

Folotyn (Pralatrexate Injection) for the Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma: U.S. Food and Drug Administration Drug Approval Summary

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Shakun M. Malik, Ke Liu, Xu Qiang, Rajeshwari Sridhara, Shenghui Tang, W. David McGuinn, Jr., S. Leigh Verbois, Anshu Marathe, Gene M. Williams, Julie Bullock, Christoffer Tornoe, Sue Ching Lin, Terrance Ocheltree, Milinda Vialpando, Alice Kacuba, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2010) 16 (20): 4921–4927.
https://doi.org/10.1158/1078-0432.CCR-10-1214
Published: 13 October 2010
View articletitled, Folotyn (Pralatrexate Injection) for the Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma: U.S. Food and Drug Administration Drug Approval Summary
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