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Ann T. Farrell
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Journal Articles

FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

E. Dianne Pulte, Kelly J. Norsworthy, Yaping Wang, Qing Xu, Hisham Qosa, Ramadevi Gudi, Donna Przepiorka, Wentao Fu, Olanrewaju O. Okusanya, Kirsten B. Goldberg, R. Angelo De Claro, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (13): 3515–3521.
https://doi.org/10.1158/1078-0432.CCR-20-4271
Published: 01 July 2021
View article titled, FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a <em>FLT3</em> Mutation
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Includes: Supplementary data
Journal Articles

Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Kelly J. Norsworthy, Flora Mulkey, Emma C. Scott, Ashley F. Ward, Donna Przepiorka, Rosane Charlab, Sarah E. Dorff, Albert Deisseroth, Dickran Kazandjian, Rajeshwari Sridhara, Julia A. Beaver, Ann T. Farrell, R. Angelo de Claro, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (16): 4280–4288.
https://doi.org/10.1158/1078-0432.CCR-20-0834
Published: 14 August 2020
View article titled, Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Emily Y. Jen, Xin Gao, Liang Li, Luning Zhuang, Natalie E. Simpson, Baikuntha Aryal, Rong Wang, Donna Przepiorka, Yuan Li Shen, Ruby Leong, Chao Liu, Christopher M. Sheth, Steven Bowen, Kirsten B. Goldberg, Ann T. Farrell, Gideon M. Blumenthal, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (3): 532–536.
https://doi.org/10.1158/1078-0432.CCR-19-2329
Published: 03 February 2020
View article titled, FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

Yvette L. Kasamon, Haiyan Chen, R. Angelo de Claro, Lei Nie, Jingjing Ye, Gideon M. Blumenthal, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (24): 7275–7280.
https://doi.org/10.1158/1078-0432.CCR-19-2030
Published: 13 December 2019
View article titled, FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia

Kelly J. Norsworthy, Kunthel By, Sriram Subramaniam, Luning Zhuang, Pedro L. Del Valle, Donna Przepiorka, Yuan-Li Shen, Christopher M. Sheth, Chao Liu, Ruby Leong, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (20): 6021–6025.
https://doi.org/10.1158/1078-0432.CCR-19-0365
Published: 15 October 2019
View article titled, FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation

Kelly J. Norsworthy, Lola Luo, Vicky Hsu, Ramadevi Gudi, Sarah E. Dorff, Donna Przepiorka, Albert Deisseroth, Yuan-Li Shen, Christopher M. Sheth, Rosane Charlab, Gene M. Williams, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (11): 3205–3209.
https://doi.org/10.1158/1078-0432.CCR-18-3749
Published: 03 June 2019
View article titled, FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia

Aviva C. Krauss, Xin Gao, Liang Li, Michael L. Manning, Paresma Patel, Wentao Fu, Kumar G. Janoria, Gerlie Gieser, David A. Bateman, Donna Przepiorka, Yuan Li Shen, Stacy S. Shord, Christopher M. Sheth, Anamitro Banerjee, Jiang Liu, Kirsten B. Goldberg, Ann T. Farrell, Gideon M. Blumenthal, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (9): 2685–2690.
https://doi.org/10.1158/1078-0432.CCR-18-2990
Published: 01 May 2019
View article titled, FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia
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Includes: Supplementary data
Journal Articles

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease

Emily Y. Jen, Qing Xu, Aaron Schetter, Donna Przepiorka, Yuan Li Shen, Donna Roscoe, Rajeshwari Sridhara, Albert Deisseroth, Reena Philip, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (2): 473–477.
https://doi.org/10.1158/1078-0432.CCR-18-2337
Published: 15 January 2019
View article titled, FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease
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Includes: Supplementary data
Journal Articles

FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia

Emily Y. Jen, Chia-Wen Ko, Jee Eun Lee, Pedro L. Del Valle, Antonina Aydanian, Charles Jewell, Kelly J. Norsworthy, Donna Przepiorka, Lei Nie, Jiang Liu, Christopher M. Sheth, Marjorie Shapiro, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (14): 3242–3246.
https://doi.org/10.1158/1078-0432.CCR-17-3179
Published: 15 July 2018
View article titled, FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia
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Includes: Supplementary data
Journal Articles

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Nicole J. Gormley, Chia-Wen Ko, Albert Deisseroth, Lei Nie, Edvardas Kaminskas, Natasha Kormanik, Kirsten B. Goldberg, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (22): 6759–6763.
https://doi.org/10.1158/1078-0432.CCR-16-2870
Published: 14 November 2017
View article titled, FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
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Journal Articles

The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications

Kenneth C. Anderson, Daniel Auclair, Gary J. Kelloff, Caroline C. Sigman, Hervé Avet-Loiseau, Ann T. Farrell, Nicole J. Gormley, Shaji K. Kumar, Ola Landgren, Nikhil C. Munshi, Michele Cavo, Faith E. Davies, Alessandra Di Bacco, Jennifer S. Dickey, Steven I. Gutman, Howard R. Higley, Mohamad A. Hussein, J. Milburn Jessup, Ilan R. Kirsch, Richard F. Little, Robert D. Loberg, Jens G. Lohr, Lata Mukundan, James L. Omel, Trevor J. Pugh, Gregory H. Reaman, Michael D. Robbins, A. Kate Sasser, Nancy Valente, Elena Zamagni
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (15): 3980–3993.
https://doi.org/10.1158/1078-0432.CCR-16-2895
Published: 01 August 2017
View article titled, The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications
Open the PDF for The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications in another window
Includes: Supplementary data
Journal Articles

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response

Paul G. Kluetz, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (22): 5618.
https://doi.org/10.1158/1078-0432.CCR-16-2140
Published: 14 November 2016
View article titled, Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response
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Journal Articles

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms

Paul G. Kluetz, Ashley Slagle, Elektra J. Papadopoulos, Laura Lee Johnson, Martha Donoghue, Virginia E. Kwitkowski, Wen-Hung Chen, Rajeshwari Sridhara, Ann T. Farrell, Patricia Keegan, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (7): 1553–1558.
https://doi.org/10.1158/1078-0432.CCR-15-2035
Published: 31 March 2016
View article titled, Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
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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

FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Hyon-Zu Lee, Virginia E. Kwitkowski, Pedro L. Del Valle, M. Stacey Ricci, Haleh Saber, Bahru A. Habtemariam, Julie Bullock, Erik Bloomquist, Yuan Li Shen, Xiao-Hong Chen, Janice Brown, Nitin Mehrotra, Sarah Dorff, Rosane Charlab, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (12): 2666–2670.
https://doi.org/10.1158/1078-0432.CCR-14-3119
Published: 14 June 2015
View article titled, FDA Approval: Belinostat for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
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Journal Articles

FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma

Barry W. Miller, Donna Przepiorka, R. Angelo de Claro, Kyung Lee, Lei Nie, Natalie Simpson, Ramadevi Gudi, Haleh Saber, Stacy Shord, Julie Bullock, Dhananjay Marathe, Nitin Mehrotra, Li Shan Hsieh, Debasis Ghosh, Janice Brown, Robert C. Kane, Robert Justice, Edvardas Kaminskas, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (7): 1525–1529.
https://doi.org/10.1158/1078-0432.CCR-14-2522
Published: 31 March 2015
View article titled, FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma
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Includes: Supplementary data
Journal Articles

U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia

Hyon-Zu Lee, Barry W. Miller, Virginia E. Kwitkowski, Stacey Ricci, Pedro DelValle, Haleh Saber, Joseph Grillo, Julie Bullock, Jeffry Florian, Nitin Mehrotra, Chia-Wen Ko, Lei Nie, Marjorie Shapiro, Mate Tolnay, Robert C. Kane, Edvardas Kaminskas, Robert Justice, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2014) 20 (15): 3902–3907.
https://doi.org/10.1158/1078-0432.CCR-14-0516
Published: 31 July 2014
View article titled, U.S. Food and Drug Administration Approval: Obinutuzumab in Combination with Chlorambucil for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia
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Journal Articles

U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Thomas M. Herndon, Albert Deisseroth, Edvardas Kaminskas, Robert C. Kane, Kallappa M. Koti, Mark D. Rothmann, Bahru Habtemariam, Julie Bullock, Jeffrey D. Bray, Jessica Hawes, Todd R. Palmby, Josephine Jee, William Adams, Houda Mahayni, Janice Brown, Angelica Dorantes, Rajeshwari Sridhara, Ann T. Farrell, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2013) 19 (17): 4559–4563.
https://doi.org/10.1158/1078-0432.CCR-13-0755
Published: 02 September 2013
View article titled, U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma
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Journal Articles

Sorafenib for the Treatment of Advanced Renal Cell Carcinoma

Robert C. Kane, Ann T. Farrell, Haleh Saber, Shenghui Tang, Gene Williams, Josephine M. Jee, Chengyi Liang, Brian Booth, Nallaperumal Chidambaram, David Morse, Rajeshwari Sridhara, Patricia Garvey, Robert Justice, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2006) 12 (24): 7271–7278.
https://doi.org/10.1158/1078-0432.CCR-06-1249
Published: 22 December 2006
View article titled, Sorafenib for the Treatment of Advanced Renal Cell Carcinoma
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