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Journal Articles

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

Melanie Royce, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, C.J. George Chang, Tiffany K. Ricks, Krithika A. Shetty, Jeffrey Kraft, Junshan Qiu, Pengfei Song, Rosane Charlab, Jingyu Yu, Kathryn E. King, Anshu Rastogi, Brian Janelsins, Wendy C. Weinberg, Kathleen Clouse, Vicky Borders-Hemphill, Lindsey Brown, Candace Gomez-Broughton, Zhong Li, Thuy Thanh Nguyen, Zhihao Qiu, Anh-Thy Ly, Suyoung Chang, Tingting Gao, Chi-Ming Tu, Bellinda King-Kallimanis, William F. Pierce, Kelly Chiang, Clara Lee, Kirsten B. Goldberg, John K. Leighton, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (8): 1487–1492.
https://doi.org/10.1158/1078-0432.CCR-21-3247
Published: 14 April 2022
View article titled, FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer
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Journal Articles

FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer

Preeti Narayan, Christy L. Osgood, Harpreet Singh, Haw-Jyh Chiu, Tiffany K. Ricks, Edwin Chiu Yuen Chow, Junshan Qiu, Pengfei Song, Jingyu Yu, Frances Namuswe, Maria Guiterrez-Lugo, Sherry Hou, William F. Pierce, Kirsten B. Goldberg, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (16): 4478–4485.
https://doi.org/10.1158/1078-0432.CCR-20-4557
Published: 15 August 2021
View article titled, FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer
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Journal Articles

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Yutao Gong, Hui Zhang, Erik W. Bloomquist, Xiling Jiang, Junshan Qiu, Jingyu Yu, Pengfei Song, Nam Atiqur Rahman, Haw-Jyh Chiu, Tiffany K. Ricks, Fatima Rizvi, Sherry Hou, Willie Wilson, Abde M. Abukhdeir, Jeffrey Seidman, Soma Ghosh, Reena Philip, William F. Pierce, Vishal Bhatnagar, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2126–2129.
https://doi.org/10.1158/1078-0432.CCR-20-3474
Published: 15 April 2021
View article titled, FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer
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Journal Articles

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer

Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1850–1854.
https://doi.org/10.1158/1078-0432.CCR-20-3119
Published: 01 April 2021
View article titled, FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer
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Journal Articles

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1842–1849.
https://doi.org/10.1158/1078-0432.CCR-20-3652
Published: 01 April 2021
View article titled, FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-20-2701
Published: 01 March 2021
View article titled, FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer
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Journal Articles

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

Elaine Chang, Chana Weinstock, Lijun Zhang, Rosane Charlab, Sarah E. Dorff, Yutao Gong, Vicky Hsu, Fang Li, Tiffany K. Ricks, Pengfei Song, Shenghui Tang, Peter E. Waldron, Jingyu Yu, Eias Zahalka, Kirsten B. Goldberg, Richard Pazdur, Marc R. Theoret, Amna Ibrahim, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 922–927.
https://doi.org/10.1158/1078-0432.CCR-20-2275
Published: 15 February 2021
View article titled, FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma
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Journal Articles

FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1

Preeti Narayan, Sakar Wahby, Jennifer J. Gao, Laleh Amiri-Kordestani, Amna Ibrahim, Erik Bloomquist, Shenghui Tang, Yuan Xu, Jiang Liu, Wentao Fu, Pengfei Song, Bellinda L. King-Kallimanis, Sherry Hou, Yutao Gong, Shyam Kalavar, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Marc R. Theoret, Gideon M. Blumenthal, Paul G. Kluetz, Rajeshwari Sridhara, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (10): 2284–2289.
https://doi.org/10.1158/1078-0432.CCR-19-3545
Published: 15 May 2020
View article titled, FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-18-0042
Published: 04 September 2018
View article titled, FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
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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.
https://doi.org/10.1158/1078-0432.CCR-17-1337
Published: 30 November 2017
View article titled, FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <em>BRCA</em> Mutation–Associated Advanced Ovarian Cancer
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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.
https://doi.org/10.1158/1078-0432.CCR-16-1073
Published: 15 January 2017
View article titled, U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma
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Journal Articles

FDA Approval: Blinatumomab

Donna Przepiorka, Chia-Wen Ko, Albert Deisseroth, Carolyn L. Yancey, Reyes Candau-Chacon, Haw-Jyh Chiu, Brenda J. Gehrke, Candace Gomez-Broughton, Robert C. Kane, Susan Kirshner, Nitin Mehrotra, Tiffany K. Ricks, Deborah Schmiel, Pengfei Song, Ping Zhao, Qing Zhou, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (18): 4035–4039.
https://doi.org/10.1158/1078-0432.CCR-15-0612
Published: 14 September 2015
View article titled, FDA Approval: Blinatumomab
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Includes: Supplementary data
Journal Articles

FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer

Sean Khozin, Gideon M. Blumenthal, Lijun Zhang, Shenghui Tang, Margaret Brower, Emily Fox, Whitney Helms, Ruby Leong, Pengfei Song, Yuzhuo Pan, Qi Liu, Ping Zhao, Hong Zhao, Donghao Lu, Zhe Tang, Ali Al Hakim, Karen Boyd, Patricia Keegan, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (11): 2436–2439.
https://doi.org/10.1158/1078-0432.CCR-14-3157
Published: 31 May 2015
View article titled, FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-14-0012
Published: 01 September 2014
View article titled, FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast 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

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 article titled, 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

Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary

Paul G. Kluetz, William Pierce, V. Ellen Maher, Hui Zhang, Shenghui Tang, Pengfei Song, Qi Liu, Martin T. Haber, Eldon E. Leutzinger, Ali Al-Hakim, Wei Chen, Todd Palmby, Elleni Alebachew, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (1): 9–14.
https://doi.org/10.1158/1078-0432.CCR-13-2665
Published: 05 January 2014
View article titled, Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary
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Journal Articles

First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer

Gideon M. Blumenthal, Nancy S. Scher, Patricia Cortazar, Somesh Chattopadhyay, Shenghui Tang, Pengfei Song, Qi Liu, Kimberly Ringgold, Anne M. Pilaro, Amy Tilley, Kathryn E. King, Laurie Graham, Barbara L. Rellahan, Wendy C. Weinberg, Bo Chi, Colleen Thomas, Patricia Hughes, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (18): 4911–4916.
https://doi.org/10.1158/1078-0432.CCR-13-1212
Published: 16 September 2013
View article titled, First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer
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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

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 article titled, 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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