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Journal Articles

FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma

Jaleh Fallah, Brian L. Heiss, Hee-Koung Joeng, Chana Weinstock, Xin Gao, William F. Pierce, Benjamin Chukwurah, Vishal Bhatnagar, Mallorie H. Fiero, Laleh Amiri-Kordestani, Richard Pazdur, Paul G. Kluetz, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (22): 5003–5008.
https://doi.org/10.1158/1078-0432.CCR-24-1199
Published: 15 November 2024
View article titled, FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma
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Includes: Supplementary data
Journal Articles

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

Michael H. Brave, William F. Maguire, Chana Weinstock, Hui Zhang, Xin Gao, Fang Li, Jingyu Yu, Wentao Fu, Hong Zhao, William F. Pierce, Elaine Chang, Jeannette Dinin, Mallorie H. Fiero, Nam Atiqur Rahman, Shenghui Tang, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (21): 4815–4821.
https://doi.org/10.1158/1078-0432.CCR-24-1393
Published: 01 November 2024
View article titled, FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
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Includes: Supplementary data
Journal Articles

A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma

Elaine Chang, Jiaxi Zhou, Chi Song, Haley Gittleman, Laura Fernandes, Chana Weinstock, Michael B. Atkins, Sundeep Agrawal, Rajeshwari Sridhara, Nicole Gormley, Shenghui Tang, Daniel L. Suzman, Laleh Amiri-Kordestani, Paul G. Kluetz, Richard Pazdur, Brian I. Rini, David F. McDermott, Meredith M. Regan
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (15): 3282–3286.
https://doi.org/10.1158/1078-0432.CCR-23-3719
Published: 01 August 2024
View article titled, A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma

William F. Maguire, Daniel Lee, Chana Weinstock, Xin Gao, Catharine C. Bulik, Sundeep Agrawal, Elaine Chang, Salaheldin S. Hamed, Erik W. Bloomquist, Shenghui Tang, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani, Daniel L. Suzman
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (10): 2011–2016.
https://doi.org/10.1158/1078-0432.CCR-23-3738
Published: 15 May 2024
View article titled, FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma
Open the PDF for FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Belzutifan for VHL Disease Tumors—Response

Jaleh Fallah, Chana Weinstock, Gautam U. Mehta, Michael H. Brave, William F. Pierce, Richard Pazdur, Abhilasha Nair, Daniel L. Suzman, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (3): 685.
https://doi.org/10.1158/1078-0432.CCR-22-3428
Published: 01 February 2023
View article titled, FDA Approval Summary: Belzutifan for VHL Disease Tumors—Response
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Journal Articles

FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors

Jaleh Fallah, Michael H. Brave, Chana Weinstock, Gautam U. Mehta, Diana Bradford, Haley Gittleman, Erik W. Bloomquist, Rosane Charlab, Salaheldin S. Hamed, Claudia P. Miller, Sarah E. Dorff, Wiley A. Chambers, Bronwyn D. Mixter, Jeannette Dinin, William F. Pierce, Tiffany K. Ricks, Shenghui Tang, Martha Donoghue, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (22): 4843–4848.
https://doi.org/10.1158/1078-0432.CCR-22-1054
Published: 14 November 2022
View article titled, FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors
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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.
https://doi.org/10.1158/1078-0432.CCR-21-2334
Published: 01 February 2022
View article titled, FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma
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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

Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies

Jamie R. Brewer, Elaine Chang, Sundeep Agrawal, Harpreet Singh, Daniel L. Suzman, James Xu, Chana Weinstock, Laura L. Fernandes, Joyce Cheng, Lijun Zhang, Diqiong Xie, Kirsten B. Goldberg, Erik W. Bloomquist, Shenghui Tang, Rajeshwari Sridhara, Marc R. Theoret, Richard Pazdur, Amna Ibrahim, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (24): 6406–6411.
https://doi.org/10.1158/1078-0432.CCR-19-4229
Published: 15 December 2020
View article titled, Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies
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Journal Articles

An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer

Michael Brave, Chana Weinstock, Jamie R. Brewer, Dow-Chung Chi, Daniel L. Suzman, Joyce Cheng, Lijun Zhang, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (18): 4717–4722.
https://doi.org/10.1158/1078-0432.CCR-19-3835
Published: 15 September 2020
View article titled, An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer
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Includes: Supplementary data
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 article titled, U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non–Small Cell Lung Cancer
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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
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (9): 2131–2135.
https://doi.org/10.1158/1078-0432.CCR-16-1773
Published: 30 April 2017
View article titled, Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer
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