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Haw-Jyh Chiu
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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: 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: 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
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Journal Articles

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Geoffrey Kim, Gwynn Ison, Amy E. McKee, Hui Zhang, Shenghui Tang, Thomas Gwise, Rajeshwari Sridhara, Eunice Lee, Abraham Tzou, Reena Philip, Haw-Jyh Chiu, Tiffany K. Ricks, Todd Palmby, Anne Marie Russell, Gaetan Ladouceur, Elimika Pfuma, Hongshan Li, Liang Zhao, Qi Liu, Rajesh Venugopal, Amna Ibrahim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (19): 4257–4261.
https://doi.org/10.1158/1078-0432.CCR-15-0887
Published: 30 September 2015
View article titled, FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline <em>BRCA</em>-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
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Journal Articles

FDA Approval: Blinatumomab

Donna Przepiorka, Chia-Wen Ko, Albert Deisseroth, Carolyn L. Yancey, Reyes Candau-Chacon, Haw-Jyh Chiu, Brenda J. Gehrke, Candace Gomez-Broughton, Robert C. Kane, Susan Kirshner, Nitin Mehrotra, Tiffany K. Ricks, Deborah Schmiel, Pengfei Song, Ping Zhao, Qing Zhou, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (18): 4035–4039.
https://doi.org/10.1158/1078-0432.CCR-15-0612
Published: 14 September 2015
View article titled, FDA Approval: Blinatumomab
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Includes: Supplementary data
Journal Articles

FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia

R. Angelo de Claro, Karen M. McGinn, Nicole Verdun, Shwu-Luan Lee, Haw-Jyh Chiu, Haleh Saber, Margaret E. Brower, C.J. George Chang, Elimika Pfuma, Bahru Habtemariam, Julie Bullock, Yun Wang, Lei Nie, Xiao-Hong Chen, Donghao (Robert) Lu, Ali Al-Hakim, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (16): 3586–3590.
https://doi.org/10.1158/1078-0432.CCR-14-2225
Published: 13 August 2015
View article titled, FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia
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Journal Articles

Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary

Yangmin M. Ning, William Pierce, V. Ellen Maher, Stella Karuri, Sheng-Hui Tang, Haw-Jyh Chiu, Todd Palmby, Jeanne Fourie Zirkelbach, Dhananjay Marathe, Nitin Mehrotra, Qi Liu, Debasis Ghosh, Christy L. Cottrell, John Leighton, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (22): 6067–6073.
https://doi.org/10.1158/1078-0432.CCR-13-1763
Published: 14 November 2013
View article titled, Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary
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