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Journal Articles

Minimal Residual Disease (MRD) Data in Hematologic Malignancy Drug Applications and Prescribing Information: FDA Analysis

Maryam Sarraf Yazdy, Andrea C. Baines, Theresa Carioti, Rachel Ershler, Emily Y. Jen, Bindu Kanapuru, Yvette L. Kasamon, Ashley Lane, Nicholas Richardson, Marc Theoret, Nicole J. Gormley
Journal: Blood
Blood (2021) 138 (Supplement 1): 4928.
https://doi.org/10.1182/blood-2021-150446
Published: 2021
Journal Articles

Response Rate, Event-Free Survival (EFS) and Overall Survival (OS) in Higher-Risk Myelodysplastic Syndromes (HR-MDS): U.S. Food and Drug Administration (FDA) Patient-Level Analyses

Nina Kim, Jonathon Vallejo, Jonathan Herz, Thomas Gwise, R. Angelo de Claro, Marc Theoret, Richard Pazdur, Kelly J. Norsworthy
Journal: Blood
Blood (2021) 138 (Supplement 1): 2604.
https://doi.org/10.1182/blood-2021-147558
Published: 2021
Journal Articles

FDA Analysis of Screen Failures By Race in Clinical Trials of Acute Myeloid Leukemia

Dianne Pulte, MD, Guo Wei, Kelly J. Norsworthy, MD, Yutao Gong, PhD, Nicole J. Gormley, MD, Bindu Kanapuru, MD, Richard Pazdur, MD, Julie Schneider, Marc Theoret, MD, Angelo De Claro, MD
Journal: Blood
Blood (2020) 136 (Supplement 1): 23–24.
https://doi.org/10.1182/blood-2020-136363
Published: 2020
Journal Articles

FDA Analysis: Impact of Body Mass Index (BMI) on Outcomes in Relapsed-Refractory Multiple Myeloma

Rachel Ershler, MD, Bindu Kanapuru, MD, Yutao Gong, PhD, Urvi A Shah, MD, Sham Mailankody, MBBS, Ola Landgren, MD PhD, Marc Theoret, MD, Nicole J Gormley, MD, Ann T. Farrell, MD, Richard Pazdur, MD
Journal: Blood
Blood (2019) 134 (Supplement_1): 5505.
https://doi.org/10.1182/blood-2019-130551
Published: 2019