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R. Angelo de Claro
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Journal Articles

FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation

Ashley C. Woods, Kelly J. Norsworthy, Moran Choe, Brenda J. Gehrke, Haiyan Chen, Jonathon Vallejo, Lili Pan, Xiling Jiang, Hongshan Li, Jeffrey Kraft, Jiang Liu, Rosane Charlab, Olanrewaju O. Okusanya, Brian Booth, Richard Pazdur, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2025) 31 (1): 12–17.
https://doi.org/10.1158/1078-0432.CCR-24-2196
Published: 06 January 2025
View article titled, FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an <em>Isocitrate Dehydrogenase 1</em> Mutation
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation

Gulsum E. Pamuk, Edwin C.Y. Chow, Alexei C. Ionan, Haiyan Chen, Shwu-Luan Lee, Vicky Hsu, Manuela Grimstein, Nan Zheng, Jielin Sun, Rosane Charlab, Brenda J. Gehrke, Jonathon Vallejo, Lori A. Ehrlich, R. Angelo de Claro, Marc R. Theoret
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (19): 4266–4271.
https://doi.org/10.1158/1078-0432.CCR-24-1086
Published: 01 October 2024
View article titled, FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <em>T315I</em> Mutation
Open the PDF for FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <em>T315I</em> Mutation in another window
Includes: Supplementary data
Journal Articles

Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding

Jorge E. Cortes, Elisabetta Abruzzese, Elyce H. Cardonick, Sonia Hernández-Díaz, Jamie Gutierrez, Mary S. Sardegna, Erica Torres-Chavez, Miriam Dinatale, Catherine C. Lerro, Brenda J. Gehrke, Stacy S. Shord, R. Angelo De Claro, Marc R. Theoret, Peter J. DeMaria, Kelly J. Norsworthy
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (17): 3658–3666.
https://doi.org/10.1158/1078-0432.CCR-24-0826
Published: 03 September 2024
View article titled, Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding
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Journal Articles

FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation

Ashley Woods, Kelly J. Norsworthy, Xin Wang, Jonathon Vallejo, Edwin Chiu Yuen Chow, Ruo-Jing Li, Jielin Sun, Rosane Charlab, Xiling Jiang, Richard Pazdur, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (7): 1226–1231.
https://doi.org/10.1158/1078-0432.CCR-23-2234
Published: 01 April 2024
View article titled, FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an <em>IDH1</em> Mutation
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Includes: Supplementary data
Journal Articles

Project Confirm: Accelerated Drug Approvals for CML—Response

Kendra L. Sweet, Jorge E. Cortes, Jane F. Apperley, Mel Mann, Michael J. Mauro, Vivian G. Oehler, Cristina Ruiz, Charles A. Schiffer, Lori A. Ehrlich, Gulsum E. Pamuk, Joseph Wynne, Gautam U. Mehta, Olanrewaju O. Okusanya, R. Angelo de Claro, Marc R. Theoret, B. Douglas Smith, Kelly J. Norsworthy
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (1): 237–238.
https://doi.org/10.1158/1078-0432.CCR-23-3234
Published: 05 January 2024
View article titled, Project Confirm: Accelerated Drug Approvals for CML—Response
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Journal Articles

Considerations for Drug Development in Myelodysplastic Syndromes

Mikkael A. Sekeres, Nina Kim, Amy E. DeZern, Kelly J. Norsworthy, Jacqueline S. Garcia, R. Angelo de Claro, Marc R. Theoret, Emily Y. Jen, Lori A. Ehrlich, Amer M. Zeidan, Rami S. Komrokji
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (14): 2573–2579.
https://doi.org/10.1158/1078-0432.CCR-22-3348
Published: 14 July 2023
View article titled, Considerations for Drug Development in Myelodysplastic Syndromes
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Journal Articles

Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia

Kendra L. Sweet, Jorge E. Cortes, Jane F. Apperley, Mel Mann, Michael J. Mauro, Vivian G. Oehler, Cristina Ruiz, Charles A. Schiffer, Lori A. Ehrlich, Gulsum E. Pamuk, Joseph Wynne, Gautam U. Mehta, R. Angelo de Claro, Marc R. Theoret, B. Douglas Smith, Kelly J. Norsworthy
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (12): 2179–2183.
https://doi.org/10.1158/1078-0432.CCR-22-2628
Published: 13 June 2023
View article titled, Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia
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Journal Articles

FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes

Nina Kim, Kelly J. Norsworthy, Sriram Subramaniam, Haiyan Chen, Michael L. Manning, Eliford Kitabi, Justin Earp, Lori A. Ehrlich, Olanrewaju O. Okusanya, Jonathon Vallejo, Brenda J. Gehrke, R. Angelo de Claro, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (16): 3411–3416.
https://doi.org/10.1158/1078-0432.CCR-21-4498
Published: 15 August 2022
View article titled, FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy

Emily Y. Jen, Xin Wang, Meng Li, Hongshan Li, Shwu-Luan Lee, Nina Ni, Donna Przepiorka, Jonathon Vallejo, Ruby Leong, Lian Ma, Brenda J. Gehrke, Sherita McLamore, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (14): 2989–2993.
https://doi.org/10.1158/1078-0432.CCR-21-4525
Published: 15 July 2022
View article titled, FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy
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Journal Articles

FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy

Donna Przepiorka, Robert Q. Le, Alexei Ionan, Ruo-Jing Li, Ying-Hong Wang, Ramadevi Gudi, Soumya Mitra, Jonathon Vallejo, Olanrewaju O. Okusanya, Lian Ma, Yuching Yang, Paresma Patel, Djelila Mezaache, Rakhi Shah, Anamitro Banerjee, Sherita McLamore, Adam N. Maung, Kirsten B. Goldberg, Richard Pazdur, Marc R. Theoret, R. Angelo De Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (12): 2488–2492.
https://doi.org/10.1158/1078-0432.CCR-21-4176
Published: 13 June 2022
View article titled, FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy
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Includes: Supplementary data
Journal Articles

Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia

Daniel A. Pollyea, John Barrett, Courtney D. DiNardo, Laura C. Michaelis, Gail J. Roboz, Robert Q. Le, Kelly J. Norsworthy, R. Angelo de Claro, Marc R. Theoret, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (5): 816–820.
https://doi.org/10.1158/1078-0432.CCR-21-2124
Published: 01 March 2022
View article titled, Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia
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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: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review

Paz J. Vellanki, Flora Mulkey, Adnan A. Jaigirdar, Lisa Rodriguez, Yibo Wang, Yuan Xu, Hong Zhao, Jiang Liu, Grant Howe, Jian Wang, Qiuyi Choo, Sarah J. Golding, Victoria Mansell, Kwadwo Korsah, Dianne Spillman, R. Angelo de Claro, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (13): 3522–3527.
https://doi.org/10.1158/1078-0432.CCR-20-4338
Published: 01 July 2021
View article titled, FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review
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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

U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program

R. Angelo de Claro, Jennifer J. Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (1): 11–14.
https://doi.org/10.1158/1078-0432.CCR-20-2220
Published: 04 January 2021
View article titled, U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program
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Journal Articles

Project Orbis: Global Collaborative Review Program

R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Michael Shum, Laila Sofia Mouawad, Gustavo Mendes Lima Santos, Kelly Robinson, Melissa Hunt, Caroline Healy, Agnes Chan, Yee Hoo Looi, Clare Rodrigues, Ulrich-Peter Rohr, Chantal Walther, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (24): 6412–6416.
https://doi.org/10.1158/1078-0432.CCR-20-3292
Published: 15 December 2020
View article titled, Project Orbis: Global Collaborative Review Program
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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: 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: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma

Najat Bouchkouj, Yvette L. Kasamon, R. Angelo de Claro, Bindu George, Xue Lin, Shiowjen Lee, Gideon M. Blumenthal, Wilson Bryan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2019) 25 (6): 1702–1708.
https://doi.org/10.1158/1078-0432.CCR-18-2743
Published: 15 March 2019
View article titled, FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
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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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