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Jeanne Fourie Zirkelbach
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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: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (18): 3573–3578.
https://doi.org/10.1158/1078-0432.CCR-23-0459
Published: 15 September 2023
View article titled, FDA Approval Summary: Selpercatinib for the Treatment of Advanced <em>RET</em> Fusion-Positive Solid Tumors
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Journal Articles

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

Timil H. Patel, Leigh Marcus, M. Naomi Horiba, Martha Donoghue, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Robert N. Schuck, Yangbing Li, Xinyuan Zhang, Jeanne Fourie Zirkelbach, Rosane Charlab, Jiang Liu, Yuching Yang, Steven J. Lemery, Richard Pazdur, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (5): 838–842.
https://doi.org/10.1158/1078-0432.CCR-22-2036
Published: 01 March 2023
View article titled, FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
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Journal Articles

FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (3): 508–512.
https://doi.org/10.1158/1078-0432.CCR-22-2072
Published: 01 February 2023
View article titled, FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with <em>EGFR</em> Exon 20 Insertion Mutations
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Journal Articles

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC

Oladimeji Akinboro, Erin Larkins, Lee H. Pai-Scherf, Luckson N. Mathieu, Yi Ren, Joyce Cheng, Mallorie H. Fiero, Wentao Fu, Youwei Bi, Shyam Kalavar, Samina Jafri, Pallavi S. Mishra-Kalyani, Jeanne Fourie Zirkelbach, Hongshan Li, Hong Zhao, Kun He, Whitney S. Helms, Meredith K. Chuk, Min Wang, Ilynn Bulatao, Jonathan Herz, Blaire L. Osborn, Yuan Xu, Jiang Liu, Yutao Gong, Sharon Sickafuse, Rebecca Cohen, Martha Donoghue, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (11): 2221–2228.
https://doi.org/10.1158/1078-0432.CCR-21-3844
Published: 01 June 2022
View article titled, FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
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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

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Abigail L. Koch, Paz J. Vellanki, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan Li Shen, Huiming Xia, Yangbing Li, Jiang Liu, Jeanne Fourie Zirkelbach, Elitza Palazov, Aleksandr Gamarian, Qiuyi Choo, Arūnas Girčys, Ulrich-Peter Rohr, Nataliya Fesenko, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (24): 6638–6643.
https://doi.org/10.1158/1078-0432.CCR-21-1034
Published: 15 December 2021
View article titled, FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review
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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: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Amy Barone, Maitreyee Hazarika, Marc R. Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5661–5665.
https://doi.org/10.1158/1078-0432.CCR-16-0664
Published: 01 October 2017
View article titled, FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma
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Journal Articles

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer

Amanda J. Walker, Suparna Wedam, Laleh Amiri-Kordestani, Erik Bloomquist, Shengui Tang, Rajeshwari Sridhara, Wei Chen, Todd R. Palmby, Jeanne Fourie Zirkelbach, Wentao Fu, Qi Liu, Amy Tilley, Geoffrey Kim, Paul G. Kluetz, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (20): 4968–4972.
https://doi.org/10.1158/1078-0432.CCR-16-0493
Published: 13 October 2016
View article titled, FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor–Positive, HER2-Negative Metastatic Breast Cancer
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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
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Journal Articles

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Geoffrey Kim, Amy E. McKee, Yang-Min Ning, Maitreyee Hazarika, Marc Theoret, John R. Johnson, Qiang Casey Xu, Shenghui Tang, Rajeshwari Sridhara, Xiaoping Jiang, Kun He, Donna Roscoe, W. David McGuinn, Whitney S. Helms, Anne Marie Russell, Sarah Pope Miksinski, Jeanne Fourie Zirkelbach, Justin Earp, Qi Liu, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (19): 4994–5000.
https://doi.org/10.1158/1078-0432.CCR-14-0776
Published: 30 September 2014
View article titled, FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAF<sup>V600E</sup> Mutation
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Journal Articles

Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: U.S. Food and Drug Administration Drug Approval Summary

Paul G. Kluetz, Yang-Min Ning, V. Ellen Maher, Lijun Zhang, Shenghui Tang, Debasis Ghosh, Robeena Aziz, Todd Palmby, Elimika Pfuma, Jeanne Fourie Zirkelbach, Nitin Mehrotra, Amy Tilley, Rajeshwari Sridhara, Amna Ibrahim, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (24): 6650–6656.
https://doi.org/10.1158/1078-0432.CCR-13-2134
Published: 16 December 2013
View article titled, Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: U.S. Food and Drug Administration Drug Approval Summary
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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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