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Journal Articles

Safety, Efficacy, and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03

Clin Cancer Res (2022) 28 (3): 489–497.

DOI: https://doi.org/10.1158/1078-0432.CCR-21-2210

Published: 01 February 2022

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Includes: Supplementary data

Journal Articles

FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

Leigh Marcus, Martha Donoghue, Stephanie Aungst, Claire E. Myers, Whitney S. Helms, Guoxiang Shen, Hong Zhao, Olen Stephens, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2021) 27 (4): 928–932.

DOI: https://doi.org/10.1158/1078-0432.CCR-20-2771

Published: 15 February 2021

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Journal Articles

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue, William F. Pierce, Stacy S. Shord, Jennifer J. Gao, Richard Pazdur

Clin Cancer Res (2021) 27 (4): 916–921.

DOI: https://doi.org/10.1158/1078-0432.CCR-20-3213

Published: 15 February 2021

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Journal Articles

Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop

Clin Cancer Res (2021) 27 (2): 394–401.

DOI: https://doi.org/10.1158/1078-0432.CCR-20-3285

Published: 19 January 2021

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Journal Articles

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

Leigh Marcus, Steven J. Lemery, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2019) 25 (13): 3753–3758.

DOI: https://doi.org/10.1158/1078-0432.CCR-18-4070

Published: 01 July 2019

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Journal Articles

FDA's Approval of the First Biosimilar to Bevacizumab

Sandra J. Casak, Steven J. Lemery, Jee Chung, Chana Fuchs, Sarah J. Schrieber, Edwin C.Y. Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne Rowzee, Sue Lim, Patricia Keegan, Amy E. McKee, Richard Pazdur

Clin Cancer Res (2018) 24 (18): 4365–4370.

DOI: https://doi.org/10.1158/1078-0432.CCR-18-0566

Published: 14 September 2018

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Journal Articles

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

Amy Barone, Dow-Chung Chi, Marc R. Theoret, Huanyu Chen, Kun He, Dubravka Kufrin, Whitney S. Helms, Sriram Subramaniam, Hong Zhao, Anuja Patel, Kirsten B. Goldberg, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (24): 7448–7453.

DOI: https://doi.org/10.1158/1078-0432.CCR-17-0898

Published: 14 December 2017

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Journal Articles

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

Christy L. Osgood, Meredith K. Chuk, Marc R. Theoret, Lan Huang, Kun He, Leah Her, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (21): 6384–6389.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-2422

Published: 31 October 2017

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Journal Articles

FDA Approval Summary: Sonidegib—Response

Stacy S. Shord, Denise Casey, Hong Zhao, Suzanne Demko, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (19): 5994.

DOI: https://doi.org/10.1158/1078-0432.CCR-17-2135

Published: 01 October 2017

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Journal Articles

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

Meredith K. Chuk, Jennie T. Chang, Marc R. Theoret, Emmanuel Sampene, Kun He, Shawna L. Weis, Whitney S. Helms, Runyan Jin, Hongshan Li, Jingyu Yu, Hong Zhao, Liang Zhao, Mark Paciga, Deborah Schmiel, Rashmi Rawat, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (19): 5666–5670.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-0663

Published: 01 October 2017

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Journal Articles

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Amy Barone, Maitreyee Hazarika, Marc R. Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (19): 5661–5665.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-0664

Published: 01 October 2017

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Journal Articles

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

Maitreyee Hazarika, Meredith K. Chuk, Marc R. Theoret, Sirisha Mushti, Kun He, Shawna L. Weis, Alexander H. Putman, Whitney S. Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (14): 3484–3488.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-0712

Published: 13 July 2017

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Journal Articles

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAF^V600 Wild-Type Unresectable or Metastatic Melanoma

Julia A. Beaver, Marc R. Theoret, Sirisha Mushti, Kun He, Meredith Libeg, Kirsten Goldberg, Rajeshwari Sridhara, Amy E. McKee, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (14): 3479–3483.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-0714

Published: 13 July 2017

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Journal Articles

FDA Approval Summary: TAS-102

Leigh Marcus, Steven J. Lemery, Sachia Khasar, Emily Wearne, Whitney S. Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (12): 2924–2927.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-2157

Published: 14 June 2017

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Journal Articles

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Denise Casey, Suzanne Demko, Stacy Shord, Hong Zhao, Huanyu Chen, Kun He, Alexander Putman, Whitney Helms, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (10): 2377–2381.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-2051

Published: 14 May 2017

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Journal Articles

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

Sean Khozin, Chana Weinstock, Gideon M. Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab, Ingrid Fan, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2017) 23 (9): 2131–2135.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-1773

Published: 30 April 2017

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Journal Articles

FDA's Approach to Regulating Biosimilars

Steven J. Lemery, M. Stacey Ricci, Patricia Keegan, Amy E. McKee, Richard Pazdur

Clin Cancer Res (2017) 23 (8): 1882–1885.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-1354

Published: 13 April 2017

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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

Clin Cancer Res (2016) 22 (22): 5618.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-2140

Published: 14 November 2016

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Journal Articles

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study

Kun He, Huanyu Chen, Thomas Gwise, Sandra Casak, Steven Lemery, Patricia Keegan, Richard Pazdur, Rajeshwari Sridhara

Clin Cancer Res (2016) 22 (21): 5167–5170.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-1010

Published: 31 October 2016

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Journal Articles

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib

Erin Larkins, Gideon M. Blumenthal, Huanyu Chen, Kun He, Rajiv Agarwal, Gerlie Gieser, Olen Stephens, Eias Zahalka, Kimberly Ringgold, Whitney Helms, Stacy Shord, Jingyu Yu, Hong Zhao, Gina Davis, Amy E. McKee, Patricia Keegan, Richard Pazdur

Clin Cancer Res (2016) 22 (21): 5171–5176.

DOI: https://doi.org/10.1158/1078-0432.CCR-16-1293

Published: 31 October 2016

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NARROW

Safety, Efficacy, and Biomarker Analysis of Toripalimab in Patients with Previously Treated Advanced Urothelial Carcinoma: Results from a Multicenter Phase II Trial POLARIS-03

FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors

FDA's Approval of the First Biosimilar to Bevacizumab

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen

FDA Approval Summary: Sonidegib—Response

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAF^V600 Wild-Type Unresectable or Metastatic Melanoma

FDA Approval Summary: TAS-102

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

FDA's Approach to Regulating Biosimilars

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

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib

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