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

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non–Small Cell Lung Cancer

Chana Weinstock, Sean Khozin, Daniel Suzman, Lijun Zhang, Shenghui Tang, Sakar Wahby, Kirsten B. Goldberg, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (16): 4534–4539.
https://doi.org/10.1158/1078-0432.CCR-17-0540
Published: 14 August 2017
View articletitled, U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non–Small Cell Lung Cancer
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Journal Articles

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Julia A. Beaver, Abraham Tzou, Gideon M. Blumenthal, Amy E. McKee, Geoffrey Kim, Richard Pazdur, Reena Philip
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (6): 1368–1372.
https://doi.org/10.1158/1078-0432.CCR-16-1098
Published: 14 March 2017
View articletitled, An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies
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Includes: Supplementary data
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 articletitled, U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma
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Journal Articles

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response

Paul G. Kluetz, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (22): 5618.
https://doi.org/10.1158/1078-0432.CCR-16-2140
Published: 14 November 2016
View articletitled, Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response
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Journal Articles

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer

Amanda J. Walker, Suparna Wedam, Laleh Amiri-Kordestani, Erik Bloomquist, Shengui Tang, Rajeshwari Sridhara, Wei Chen, Todd R. Palmby, Jeanne Fourie Zirkelbach, Wentao Fu, Qi Liu, Amy Tilley, Geoffrey Kim, Paul G. Kluetz, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (20): 4968–4972.
https://doi.org/10.1158/1078-0432.CCR-16-0493
Published: 13 October 2016
View articletitled, FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
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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

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

Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle

Pasi A. Jänne, Geoffrey Kim, Alice T. Shaw, Rajeshwari Sridhara, Richard Pazdur, Amy E. McKee
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (11): 2613–2617.
https://doi.org/10.1158/1078-0432.CCR-15-2643
Published: 31 May 2016
View articletitled, Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle
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Journal Articles

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (7): 1553–1558.
https://doi.org/10.1158/1078-0432.CCR-15-2035
Published: 31 March 2016
View articletitled, Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-15-1185
Published: 01 November 2015
View articletitled, FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer
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Journal Articles

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials

Marc R. Theoret, Lee H. Pai-Scherf, Meredith K. Chuk, Tatiana M. Prowell, Sanjeeve Balasubramaniam, Tamy Kim, Geoffrey Kim, Paul G. Kluetz, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (20): 4545–4551.
https://doi.org/10.1158/1078-0432.CCR-14-3244
Published: 14 October 2015
View articletitled, Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-15-0887
Published: 30 September 2015
View articletitled, FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
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Journal Articles

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.
https://doi.org/10.1158/1078-0432.CCR-14-0776
Published: 30 September 2014
View articletitled, FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation
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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 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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