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CCR Perspectives in Drug Approval
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-15-1377
Published: 30 November 2015
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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 Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Geoffrey Kim, Gwynn Ison, Amy E. McKee, Hui Zhang, Shenghui Tang, Thomas Gwise, Rajeshwari Sridhara, Eunice Lee, Abraham Tzou, Reena Philip, Haw-Jyh Chiu, Tiffany K. Ricks, Todd Palmby, Anne Marie Russell, Gaetan Ladouceur, Elimika Pfuma, Hongshan Li, Liang Zhao, Qi Liu, Rajesh Venugopal, Amna Ibrahim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (19): 4257–4261.
DOI: https://doi.org/10.1158/1078-0432.CCR-15-0887
Published: 30 September 2015
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-15-0612
Published: 14 September 2015
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Includes: Supplementary data
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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 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.
DOI: https://doi.org/10.1158/1078-0432.CCR-15-0600
Published: 02 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: 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.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-3157
Published: 31 May 2015
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Lung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400

Roy S. Herbst, David R. Gandara, Fred R. Hirsch, Mary W. Redman, Michael LeBlanc, Philip C. Mack, Lawrence H. Schwartz, Everett Vokes, Suresh S. Ramalingam, Jeffrey D. Bradley, Dana Sparks, Yang Zhou, Crystal Miwa, Vincent A. Miller, Roman Yelensky, Yali Li, Jeff D. Allen, Ellen V. Sigal, David Wholley, Caroline C. Sigman, Gideon M. Blumenthal, Shakun Malik, Gary J. Kelloff, Jeffrey S. Abrams, Charles D. Blanke, Vassiliki A. Papadimitrakopoulou
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (7): 1514–1524.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-3473
Published: 31 March 2015
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FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma

Barry W. Miller, Donna Przepiorka, R. Angelo de Claro, Kyung Lee, Lei Nie, Natalie Simpson, Ramadevi Gudi, Haleh Saber, Stacy Shord, Julie Bullock, Dhananjay Marathe, Nitin Mehrotra, Li Shan Hsieh, Debasis Ghosh, Janice Brown, Robert C. Kane, Robert Justice, Edvardas Kaminskas, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (7): 1525–1529.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-2522
Published: 31 March 2015
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Includes: Supplementary data
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FDA Approval: Siltuximab for the Treatment of Patients with Multicentric Castleman Disease

Albert Deisseroth, Chia-Wen Ko, Lei Nie, Jeanne F. Zirkelbach, Liang Zhao, Julie Bullock, Nitin Mehrotra, Pedro Del Valle, Haleh Saber, Christopher Sheth, Brenda Gehrke, Robert Justice, Ann Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (5): 950–954.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-1678
Published: 01 March 2015
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First FDA Approval of Neoadjuvant Therapy for Breast Cancer: Pertuzumab for the Treatment of Patients with HER2-Positive Breast Cancer

Laleh Amiri-Kordestani, Suparna Wedam, Lijun Zhang, Shenghui Tang, Amy Tilley, Amna Ibrahim, Robert Justice, Richard Pazdur, Patricia Cortazar
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (21): 5359–5364.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-1268
Published: 30 October 2014
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-0776
Published: 30 September 2014
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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: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

Hyon-Zu Lee, Barry W. Miller, Virginia E. Kwitkowski, Stacey Ricci, Pedro DelValle, Haleh Saber, Joseph Grillo, Julie Bullock, Jeffry Florian, Nitin Mehrotra, Chia-Wen Ko, Lei Nie, Marjorie Shapiro, Mate Tolnay, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (15): 3902–3907.
DOI: https://doi.org/10.1158/1078-0432.CCR-14-0516
Published: 31 July 2014
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U.S. Food and Drug Administration Inspections of Clinical Investigators: Overview of Results from 1977 to 2009

Sonia K. Morgan-Linnell, David J. Stewart, Razelle Kurzrock
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (13): 3364–3370.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-3206
Published: 30 June 2014
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Includes: Supplementary data
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-3077
Published: 15 April 2014
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Predictive Value of Phase I Trials for Safety in Later Trials and Final Approved Dose: Analysis of 61 Approved Cancer Drugs

Denis L. Jardim, Kenneth R. Hess, Patricia LoRusso, Razelle Kurzrock, David S. Hong
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (2): 281–288.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-2103
Published: 16 January 2014
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Includes: Supplementary data
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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.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-2665
Published: 05 January 2014
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Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: U.S. Food and Drug Administration Drug Approval Summary

Paul G. Kluetz, Yang-Min Ning, V. Ellen Maher, Lijun Zhang, Shenghui Tang, Debasis Ghosh, Robeena Aziz, Todd Palmby, Elimika Pfuma, Jeanne Fourie Zirkelbach, Nitin Mehrotra, Amy Tilley, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (24): 6650–6656.
DOI: https://doi.org/10.1158/1078-0432.CCR-13-2134
Published: 16 December 2013
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