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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: 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 OF1–OF4.
https://doi.org/10.1158/1078-0432.CCR-23-1133
Published: 07 September 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: Ripretinib for Advanced Gastrointestinal Stromal Tumor

Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L. Mushti, Rosane Charlab, Elizabeth I. Spehalski, Hong Zhao, Matthew D. Thompson, Shenghui Tang, Richard Pazdur, Steven J. Lemery, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (11): 2020–2024.
https://doi.org/10.1158/1078-0432.CCR-22-2400
Published: 01 June 2023
View article titled, FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor
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Includes: Supplementary data
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: 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: 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

U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

Shaily Arora, Preeti Narayan, Christy L. Osgood, Suparna Wedam, Tatiana M. Prowell, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Soma Ghosh, Reena Philip, Gwynn Ison, Tara Berman, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (6): 1072–1086.
https://doi.org/10.1158/1078-0432.CCR-21-2600
Published: 14 March 2022
View article titled, U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review
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Journal Articles

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Shaily Arora, Preeti Narayan, Gwynn Ison, Tara Berman, Daniel L. Suzman, Suparna Wedam, Tatiana M. Prowell, Soma Ghosh, Reena Philip, Christy L. Osgood, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (6): 1058–1071.
https://doi.org/10.1158/1078-0432.CCR-21-2599
Published: 14 March 2022
View article titled, U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review
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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: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Luckson N. Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup K. Amatya, Mallorie H. Fiero, Pallavi S. Mishra-Kalyani, Whitney S. Helms, Claire E. Myers, Amy M. Skinner, Stephanie Aungst, Runyan Jin, Hong Zhao, Huiming Xia, Jeanne Fourie Zirkelbach, Youwei Bi, Yangbing Li, Jiang Liu, Manuela Grimstein, Xinyuan Zhang, Stacie Woods, Kelie Reece, Abdelrahmman M. Abukhdeir, Soma Ghosh, Reena Philip, Shenghui Tang, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (2): 249–254.
https://doi.org/10.1158/1078-0432.CCR-21-1566
Published: 19 January 2022
View article titled, FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
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Journal Articles

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Anup K. Amatya, Mallorie H. Fiero, Erik W. Bloomquist, Arup K. Sinha, Steven J. Lemery, Harpreet Singh, Amna Ibrahim, Martha Donoghue, Lola A. Fashoyin-Aje, R. Angelo de Claro, Nicole J. Gormley, Laleh Amiri-Kordestani, Rajeshwari Sridhara, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Shenghui Tang
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (21): 5753–5756.
https://doi.org/10.1158/1078-0432.CCR-20-4912
Published: 01 November 2021
View article titled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
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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: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2378–2382.
https://doi.org/10.1158/1078-0432.CCR-20-3901
Published: 01 May 2021
View article titled, FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Diana Bradford, Erin Larkins, Sirisha L. Mushti, Lisa Rodriguez, Amy M. Skinner, Whitney S. Helms, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Jiang Liu, Rosane Charlab, Francisca Reyes Turcu, Dun Liang, Soma Ghosh, Donna Roscoe, Reena Philip, Autumn Zack-Taylor, Shenghui Tang, Paul G. Kluetz, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2130–2135.
https://doi.org/10.1158/1078-0432.CCR-20-3558
Published: 15 April 2021
View article titled, FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with <em>RET</em> Gene Mutations or Fusions
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer

Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S. Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1850–1854.
https://doi.org/10.1158/1078-0432.CCR-20-3119
Published: 01 April 2021
View article titled, FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer
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Journal Articles

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1842–1849.
https://doi.org/10.1158/1078-0432.CCR-20-3652
Published: 01 April 2021
View article titled, FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
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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 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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