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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: Capecitabine Labeling Update under Project Renewal

Sundeep Agrawal, Clara Lee, William F. Pierce, Elizabeth Everhart, Adriene King-Ducre, Melanie Royce, Christy L. Osgood, Laleh Amiri-Kordestani, Haw-Jyh Chiu, Tiffany K. Ricks, Lili Pan, Jeanne Fourie Zirkelbach, Rosane Charlab, Michael Pacanowski, Tamy Kim, Richard Pazdur, Paul G. Kluetz, Jennifer J. Gao
Journal: Clinical Cancer Research
Clin Cancer Res OF1–OF7.
https://doi.org/10.1158/1078-0432.CCR-24-1708
Published: 08 November 2024
View article titled, FDA Approval Summary: Capecitabine Labeling Update under Project Renewal
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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

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Zhou Feng, Erik W. Bloomquist, Shenghui Tang, C.J. George Chang, Tiffany K. Ricks, Sherry C. Hou, William F. Pierce, Donna R. Rivera, Richard Pazdur, Paul G. Kluetz, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (24): 5008–5011.
https://doi.org/10.1158/1078-0432.CCR-23-1133
Published: 15 December 2023
View article titled, FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
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Journal Articles

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer

Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H. Fiero, Ankit Shah, Salaheldin S. Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K. Ricks, Rajan Pragani, Arulvathani Arudchandran, Paresma Patel, Shadia Zaman, Arpita Roy, Shyam Kalavar, Soma Ghosh, William F. Pierce, Nam Atiqur Rahman, Shenghui Tang, Bronwyn D. Mixter, Paul G. Kluetz, Richard Pazdur, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (19): 3835–3840.
https://doi.org/10.1158/1078-0432.CCR-23-0991
Published: 02 October 2023
View article titled, FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer
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Journal Articles

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer

Jaleh Fallah, Sundeep Agrawal, Haley Gittleman, Mallorie H. Fiero, Sriram Subramaniam, Christy John, Wei Chen, Tiffany K. Ricks, Gang Niu, Anthony Fotenos, Min Wang, Kelly Chiang, William F. Pierce, Daniel L. Suzman, Shenghui Tang, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Paul G. Kluetz
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (9): 1651–1657.
https://doi.org/10.1158/1078-0432.CCR-22-2875
Published: 01 May 2023
View article titled, FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer
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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: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer

Mirat Shah, Christy L. Osgood, Anup K. Amatya, Mallorie H. Fiero, William F. Pierce, Abhilasha Nair, Jonathan Herz, Kim J. Robertson, Bronwyn D. Mixter, Shenghui Tang, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (24): 5249–5253.
https://doi.org/10.1158/1078-0432.CCR-22-1110
Published: 15 December 2022
View article titled, FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer
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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: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Sandra J. Casak, Shan Pradhan, Lola A. Fashoyin-Aje, Yi Ren, Yuan-Li Shen, Yuan Xu, Edwin Chiu Yuen Chow, Ye Xiong, Jeanne Fourie Zirklelbach, Jiang Liu, Rosane Charlab, William F. Pierce, Nataliya Fesenko, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (13): 2733–2737.
https://doi.org/10.1158/1078-0432.CCR-21-4462
Published: 01 July 2022
View article titled, FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation
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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: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

Sandra J. Casak, Leigh Marcus, Lola Fashoyin-Aje, Sirisha L. Mushti, Joyce Cheng, Yuan-Li Shen, William F. Pierce, Leah Her, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (17): 4680–4684.
https://doi.org/10.1158/1078-0432.CCR-21-0557
Published: 01 September 2021
View article titled, FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma
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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: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Sandra J. Casak, Martha Donoghue, Lola Fashoyin-Aje, Xiaoping Jiang, Lisa Rodriguez, Yuan-Li Shen, Yuan Xu, Xiling Jiang, Jiang Liu, Hong Zhao, William F. Pierce, Shubhangi Mehta, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1836–1841.
https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
View article titled, FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
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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 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
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (4): 916–921.
https://doi.org/10.1158/1078-0432.CCR-20-3213
Published: 15 February 2021
View article titled, FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
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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

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Harpreet Singh, Amanda J. Walker, Laleh Amiri-Kordestani, Joyce Cheng, Shenghui Tang, Pamela Balcazar, Kimberly Barnett-Ringgold, Todd R. Palmby, Xianhua Cao, Nan Zheng, Qi Liu, Jingyu Yu, William F. Pierce, Selena R. Daniels, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (15): 3486–3491.
https://doi.org/10.1158/1078-0432.CCR-17-3628
Published: 31 July 2018
View article titled, U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
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Journal Articles

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Anand Shah, Erik Bloomquist, Shenghui Tang, Wentao Fu, Youwei Bi, Qi Liu, Jingyu Yu, Ping Zhao, Todd R. Palmby, Kirsten B. Goldberg, C.J. George Chang, Paresma Patel, Elleni Alebachew, Amy Tilley, William F. Pierce, Amna Ibrahim, Gideon M. Blumenthal, Rajeshwari Sridhara, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (13): 2999–3004.
https://doi.org/10.1158/1078-0432.CCR-17-2369
Published: 01 July 2018
View article titled, FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
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