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Nicole J. Gormley
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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 articletitled, 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 articletitled, FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma
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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 articletitled, Improving Collection and Analysis of Overall Survival Data
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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 articletitled, FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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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 articletitled, Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective
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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 articletitled, FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma
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Journal Articles

Perspectives on Drug Development in Multiple Myeloma—Looking Forward to 2025

Peter M. Voorhees, Andrzej J. Jakubowiak, Shaji K. Kumar, Bindu Kanapuru, Andrea C. Baines, Vishal Bhatnagar, Rachel Ershler, Marc R. Theoret, Nicole J. Gormley, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (1): 23–26.
https://doi.org/10.1158/1078-0432.CCR-21-1069
Published: 05 January 2022
View articletitled, Perspectives on Drug Development in Multiple Myeloma—Looking Forward to 2025
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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 articletitled, Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
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Journal Articles

The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Julie A. Schneider, Yutao Gong, Kirsten B. Goldberg, Paul G. Kluetz, Marc R. Theoret, Laleh Amiri-Kordestani, Julia A. Beaver, Lola Fashoyin-Aje, Nicole J. Gormley, Adnan A. Jaigirdar, Steven J. Lemery, Pallavi S. Mishra-Kalyani, Gregory H. Reaman, Donna R. Rivera, Wendy S. Rubinstein, Harpreet Singh, Rajeshwari Sridhara, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (19): 5161–5167.
https://doi.org/10.1158/1078-0432.CCR-20-4429
Published: 01 October 2021
View articletitled, The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology
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Includes: Supplementary data
Journal Articles

Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration

Kenneth C. Anderson, Daniel Auclair, Stacey J. Adam, Amit Agarwal, Melissa Anderson, Hervé Avet-Loiseau, Mark Bustoros, Jessica Chapman, Dana E. Connors, Ajeeta Dash, Alessandra Di Bacco, Ling Du, Thierry Facon, Juan Flores-Montero, Francesca Gay, Irene M. Ghobrial, Nicole J. Gormley, Ira Gupta, Howard Higley, Jens Hillengass, Bindu Kanapuru, Dickran Kazandjian, Gary J. Kelloff, Ilan R. Kirsch, Brandon Kremer, Ola Landgren, Elizabeth Lightbody, Oliver C. Lomas, Sagar Lonial, María-Victoria Mateos, Rocio Montes de Oca, Lata Mukundan, Nikhil C. Munshi, Elizabeth K. O'Donnell, Alberto Orfao, Bruno Paiva, Reshma Patel, Trevor J. Pugh, Karthik Ramasamy, Jill Ray, Mikhail Roshal, Jeremy A. Ross, Caroline C. Sigman, Katie L. Thoren, Suzanne Trudel, Gary Ulaner, Nancy Valente, Brendan M. Weiss, Elena Zamagni, Shaji K. Kumar
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (19): 5195–5212.
https://doi.org/10.1158/1078-0432.CCR-21-1059
Published: 01 October 2021
View articletitled, Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration
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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 articletitled, 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 articletitled, The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications
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Includes: Supplementary data