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Journal Articles

FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Elaine Chang, Chana Weinstock, Lijun Zhang, Mallorie H. Fiero, Miao Zhao, Eias Zahalka, Tiffany K. Ricks, Jeanne Fourie Zirkelbach, Junshan Qiu, Jingyu Yu, Xiao Hong Chen, Vishal Bhatnagar, Kirsten B. Goldberg, Shenghui Tang, Paul G. Kluetz, Richard Pazdur, Amna Ibrahim, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (3): 441–445.
DOI: https://doi.org/10.1158/1078-0432.CCR-21-2334
Published: 01 February 2022
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FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer

Mirat Shah, Suparna Wedam, Joyce Cheng, Mallorie H. Fiero, Huiming Xia, Fang Li, Jianghong Fan, Xinyuan Zhang, Jingyu Yu, Pengfei Song, Wei Chen, Tiffany K. Ricks, Xiao Hong Chen, Kirsten B. Goldberg, Yutao Gong, William F. Pierce, Shenghui Tang, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (5): 1220–1226.
DOI: https://doi.org/10.1158/1078-0432.CCR-20-2701
Published: 01 March 2021
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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (17): 4066–4071.
DOI: https://doi.org/10.1158/1078-0432.CCR-18-0042
Published: 04 September 2018
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Journal Articles

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation–Associated Advanced Ovarian Cancer

Sanjeeve Balasubramaniam, Julia A. Beaver, Sara Horton, Laura L. Fernandes, Shenghui Tang, Hisani N. Horne, Jinzhong Liu, Chao Liu, Sarah J. Schrieber, Jingyu Yu, Pengfei Song, William Pierce, Kim J. Robertson, Todd R. Palmby, Haw-Jyh Chiu, Eunice Y. Lee, Reena Philip, Robert Schuck, Rosane Charlab, Anamitro Banerjee, Xiao Hong Chen, Xing Wang, Kirsten B. Goldberg, Rajeshwari Sridhara, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (23): 7165–7170.
DOI: https://doi.org/10.1158/1078-0432.CCR-17-1337
Published: 30 November 2017
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Journal Articles

U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma

Harpreet Singh, Michael Brave, Julia A. Beaver, Joyce Cheng, Shenghui Tang, Eias Zahalka, Todd R. Palmby, Rajesh Venugopal, Pengfei Song, Qi Liu, Chao Liu, Jingyu Yu, Xiao Hong Chen, Xing Wang, Yaning Wang, Paul G. Kluetz, Selena R. Daniels, Elektra J. Papadopoulos, Rajeshwari Sridhara, Amy E. McKee, Amna Ibrahim, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (2): 330–335.
DOI: https://doi.org/10.1158/1078-0432.CCR-16-1073
Published: 15 January 2017
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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

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.
DOI: https://doi.org/10.1158/1078-0432.CCR-16-0638
Published: 15 September 2016
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FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer

Julia A. Beaver, Laleh Amiri-Kordestani, Rosane Charlab, Wei Chen, Todd Palmby, Amy Tilley, Jeanne Fourie Zirkelbach, Jingyu Yu, Qi Liu, Liang Zhao, Joyce Crich, Xiao Hong Chen, Minerva Hughes, Erik Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Paul G. Kluetz, Geoffrey Kim, Amna Ibrahim, Richard Pazdur, Patricia Cortazar
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (21): 4760–4766.
DOI: https://doi.org/10.1158/1078-0432.CCR-15-1185
Published: 01 November 2015
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FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia

R. Angelo de Claro, Karen M. McGinn, Nicole Verdun, Shwu-Luan Lee, Haw-Jyh Chiu, Haleh Saber, Margaret E. Brower, C.J. George Chang, Elimika Pfuma, Bahru Habtemariam, Julie Bullock, Yun Wang, Lei Nie, Xiao-Hong Chen, Donghao (Robert) Lu, Ali Al-Hakim, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (16): 3586–3590.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-2225
Published: 13 August 2015
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-3119
Published: 14 June 2015
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FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

Laleh Amiri-Kordestani, Gideon M. Blumenthal, Qiang Casey Xu, Lijun Zhang, Shenghui W. Tang, Linan Ha, Wendy C. Weinberg, Bo Chi, Reyes Candau-Chacon, Patricia Hughes, Anne M. Russell, Sarah Pope Miksinski, Xiao Hong Chen, W. David McGuinn, Todd Palmby, Sarah J. Schrieber, Qi Liu, Jian Wang, Pengfei Song, Nitin Mehrotra, Lisa Skarupa, Kathleen Clouse, Ali Al-Hakim, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur, Patricia Cortazar
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (17): 4436–4441.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-0012
Published: 01 September 2014
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U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma

R. Angelo de Claro, Karen McGinn, Virginia Kwitkowski, Julie Bullock, Aakanksha Khandelwal, Bahru Habtemariam, Yanli Ouyang, Haleh Saber, Kyung Lee, Kallappa Koti, Mark Rothmann, Marjorie Shapiro, Francisco Borrego, Kathleen Clouse, Xiao Hong Chen, Janice Brown, Lara Akinsanya, Robert Kane, Edvardas Kaminskas, Ann Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2012) 18 (21): 5845–5849.
DOI: https://doi.org/10.1158/1078-0432.CCR-12-1803
Published: 06 November 2012
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Approval Summary: Gemtuzumab Ozogamicin in Relapsed Acute Myeloid Leukemia

Peter F. Bross, Julie Beitz, Gang Chen, Xiao Hong Chen, Eric Duffy, Lydia Kieffer, Sandip Roy, Rajeshwari Sridhara, Atiqur Rahman, Grant Williams, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2001) 7 (6): 1490–1496.
Published: 01 June 2001
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