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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: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas

Maryam Sarraf Yazdy, Yvette L. Kasamon, Wenjuan Gu, Lisa R. Rodriguez, Susan Jin, Vishal Bhatnagar, Nicholas C. Richardson, Marc R. Theoret, Richard Pazdur, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (24): 5521–5526.
https://doi.org/10.1158/1078-0432.CCR-24-1729
Published: 16 December 2024
View article titled, FDA Approval Summary: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas
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Journal Articles

FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma

Andrea C. Baines, Bindu Kanapuru, Jay Zhao, Lauren S.L. Price, Nan Zheng, Robyn Konicki, Michael L. Manning, Brenda J. Gehrke, Marc R. Theoret, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (24): 5515–5520.
https://doi.org/10.1158/1078-0432.CCR-24-1872
Published: 16 December 2024
View article titled, FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma
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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
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Includes: Supplementary data
Journal Articles

Improving Collection and Analysis of Overall Survival Data

Lisa R. Rodriguez, Nicole J. Gormley, Ruixiao Lu, Anup K. Amatya, George D. Demetri, Keith T. Flaherty, Ruben A. Mesa, Richard Pazdur, Mikkael A. Sekeres, Minghua Shan, Steven Snapinn, Marc R. Theoret, Rukiya Umoja, Jonathon Vallejo, Nicholas J.H. Warren, Qing Xu, Kenneth C. Anderson
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (18): 3974–3982.
https://doi.org/10.1158/1078-0432.CCR-24-0919
Published: 13 September 2024
View article titled, Improving Collection and Analysis of Overall Survival Data
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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: Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

Kavita Natrajan, Megha Kaushal, Bindu George, Bindu Kanapuru, Marc R. Theoret
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (14): 2865–2871.
https://doi.org/10.1158/1078-0432.CCR-24-0378
Published: 15 July 2024
View article titled, FDA Approval Summary: Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
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Journal Articles

FDA Approval Summary: Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma

Mona Elmacken, Helkha Peredo-Pinto, Cong Wang, Zhenzhen Xu, Million Tegenge, Adnan A. Jaigirdar, Marc R. Theoret, Tejashri Purohit-Sheth, Yvette L. Kasamon
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (11): 2309–2316.
https://doi.org/10.1158/1078-0432.CCR-23-2967
Published: 03 June 2024
View article titled, FDA Approval Summary: Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma
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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

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Deepti Telaraja, Yvette L. Kasamon, Justin S. Collazo, Ruby Leong, Kun Wang, Ping Li, Elyes Dahmane, Yuching Yang, Justin Earp, Manuela Grimstein, Lisa R. Rodriguez, Marc R. Theoret, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (1): 17–22.
https://doi.org/10.1158/1078-0432.CCR-23-1272
Published: 05 January 2024
View article titled, FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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Journal Articles

FDA Approval Summary: Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma

Poornima Sharma, Yvette L. Kasamon, Xue Lin, Zhenzhen Xu, Marc R. Theoret, Tejashri Purohit-Sheth
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (21): 4331–4337.
https://doi.org/10.1158/1078-0432.CCR-23-0568
Published: 01 November 2023
View article titled, FDA Approval Summary: Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma
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Journal Articles

FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data

Julie A. Schneider, Julia Eckstein, Kirsten B. Goldberg, Mark C. Ascione, Thamar Bailey, Kimberly Taylor, Aisha M. Coffey, Darshini Satchi, Howard Philips, Rajeshwari Sridhara, Abhilasha Nair, Richard Pazdur, Marc R. Theoret
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (16): 2964–2972.
https://doi.org/10.1158/1078-0432.CCR-22-3240
Published: 15 August 2023
View article titled, FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data
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Includes: Supplementary data
Journal Articles

Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective

Andrea C. Baines, Maryam Sarraf Yazdy, Yvette L. Kasamon, Rachel Ershler, Emily Y. Jen, Bindu Kanapuru, Nicholas C. Richardson, Ashley Lane, Theresa Carioti, Marc R. Theoret, Richard Pazdur, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (15): 2748–2752.
https://doi.org/10.1158/1078-0432.CCR-22-3579
Published: 01 August 2023
View article titled, Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective
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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: Ripretinib for Advanced Gastrointestinal Stromal Tumor

Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L. Mushti, Rosane Charlab, Elizabeth I. Spehalski, Hong Zhao, Matthew D. Thompson, Shenghui Tang, Richard Pazdur, Steven J. Lemery, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (11): 2020–2024.
https://doi.org/10.1158/1078-0432.CCR-22-2400
Published: 01 June 2023
View article titled, FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor
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Includes: Supplementary data
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: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma

Andrea C. Baines, Rachel Ershler, Bindu Kanapuru, Qing Xu, Guoxiang Shen, Liang Li, Lian Ma, Olanrewaju O. Okusanya, Natalie E. Simpson, Wanda Nguyen, Marc R. Theoret, Richard Pazdur, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (21): 4629–4633.
https://doi.org/10.1158/1078-0432.CCR-22-0618
Published: 01 November 2022
View article titled, FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma
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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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