1-17 of 17
Jingyu Yu
Close
Save search
Follow your search
Access your saved searches in your account
Would you like to receive an alert when new items match your search?
Close Modal
Sort by
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
Open the PDF for FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer in another window
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
Open the PDF for FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer in another window
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
Open the PDF for FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma in another window
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
Open the PDF for FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer in another window
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
Open the PDF for FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer in another window
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
Open the PDF for FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer in another window
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
Open the PDF for FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer in another window
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
Open the PDF for FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma in another window
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
Open the PDF for FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy in another window
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
Open the PDF for U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer in another window
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
Open the PDF for FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer in another window
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 article titled, FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <em>BRCA</em> Mutation–Associated Advanced Ovarian Cancer
Open the PDF for FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious <em>BRCA</em> Mutation–Associated Advanced Ovarian Cancer in another window
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
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5666–5670.
https://doi.org/10.1158/1078-0432.CCR-16-0663
Published: 01 October 2017
View article titled, FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma
Open the PDF for FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma in another window
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
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (12): 2924–2927.
https://doi.org/10.1158/1078-0432.CCR-16-2157
Published: 14 June 2017
View article titled, FDA Approval Summary: TAS-102
Open the PDF for FDA Approval Summary: TAS-102 in another window
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 article titled, U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma
Open the PDF for U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma in another window
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
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (21): 5171–5176.
https://doi.org/10.1158/1078-0432.CCR-16-1293
Published: 31 October 2016
View article titled, FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib
Open the PDF for FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib in another window
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 article titled, FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer
Open the PDF for FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor–Positive, HER2-Negative Metastatic Breast Cancer in another window