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Journal Articles

Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials

Bindu Kanapuru, Laura L. Fernandes, Andrea Baines, Rachel Ershler, Vishal Bhatnagar, Elizabeth Pulte, Thomas Gwise, Marc R. Theoret, Richard Pazdur, Lola Fashoyin-Aje, Nicole Gormley

Blood (2023) 142 (3): 235–243.

https://doi.org/10.1182/blood.2022018657

Published: 2023

Journal Articles

Response Prediction to Isocitrate Dehydrogenase (IDH) Inhibitors in Patients with IDH1 - or IDH2 -Mutated Acute Myeloid Leukemia Using Clinical and Genomic Data

Blood (2021) 138 (Supplement 1): 1285.

https://doi.org/10.1182/blood-2021-147099

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

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

Blood (2020) 136 (Supplement 1): 23–24.

https://doi.org/10.1182/blood-2020-136363

Published: 2020

Journal Articles

Second Cancers in Adults with Acute Promyelocytic Leukemia (APL) Treated with or without Arsenic Trioxide (ATO): A SEER-Medicare Analysis

Kelly J. Norsworthy, MD, Steven T. Bird, PhD PharmD, MS, Armen Avagyan, MS, Yuchen Li, MS, Sandia Akhtar, BS, Jiemin Liao, MA, Michael Wernecke, BA, Albert B. Deisseroth, MD PhD, Meredith Chuk, MD, Thomas E. MaCurdy, PhD, Richard Swain, PhD, Jeffrey A. Kelman, MD MMSc, Ann T. Farrell, MD, Richard Pazdur, MD, Gideon Blumenthal, MD, David J. Graham, MD MPH

Blood (2019) 134 (Supplement_1): 3497.

https://doi.org/10.1182/blood-2019-130295

Published: 2019

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

Blood (2019) 134 (Supplement_1): 5505.

https://doi.org/10.1182/blood-2019-130551

Published: 2019

Journal Articles

FDA Analysis of Survival Outcomes in Older Adults with Relapsed-Refractory Multiple Myeloma (RRMM) Treated with Novel Drug Regimens

Bindu Kanapuru, MD, Susan Jin, Kunthel By, Theresa Carioti, Yuan-Li Shen, PhD, Rajeshwari Sridhara, PhD, Nicole J Gormley, MD, Ann T. Farrell, MD, Richard Pazdur, MD

Blood (2019) 134 (Supplement_1): 3194.

https://doi.org/10.1182/blood-2019-127141

Published: 2019

Journal Articles

Developing a Genomics Model to Predict Failure of Isocitrate Dehydrogenase (IDH) Inhibitors for Treatment of Patients with IDH1- or IDH2-Mutated Acute Myeloid Leukemia

Tigran Ghazanchyan, MS, Dickran Kazandjian, MD, Donna Przepiorka, MD PhD, Kelly J. Norsworthy, MD, Emma Scott, PhD, Luis Santana-Quintero, PhD, Svetlana Petrovskaya, PhD, Yong Zhang, PhD, Amy Rosenberg, MD, Ashutosh Rao, PhD, Richard Pazdur, MD, Ann T. Farrell, MD, Julia A. Beaver, MD, Vahan Simonyan, PhD

Blood (2018) 132 (Supplement 1): 2815.

https://doi.org/10.1182/blood-2018-99-116870

Published: 2018

Journal Articles

Incidence of Differentiation Syndrome with Ivosidenib (IVO) and Enasidenib (ENA) for Treatment of Patients with Relapsed or Refractory (R/R) Isocitrate Dehydrogenase (IDH)1- or IDH2-Mutated Acute Myeloid Leukemia (AML): A Systematic Analysis By the U.S. Food and Drug Administration (FDA)

Kelly J. Norsworthy, MD, Flora Mulkey, MS, Ashley F. Ward, MD, Donna Przepiorka, MDPhD, Albert B. Deisseroth, MD PhD, Ann T. Farrell, MD, Richard Pazdur, MD

Blood (2018) 132 (Supplement 1): 288.

https://doi.org/10.1182/blood-2018-99-117426

Published: 2018

Journal Articles

Response Rate, Event-Free Survival (EFS), and Overall Survival (OS) in Newly-Diagnosed Acute Myeloid Leukemia (AML): U.S. Food and Drug Administration (FDA) Trial-Level and Patient-Level Analyses

Kelly J. Norsworthy, MD, Xin Gao, PhD, Chia-Wen Ko, PhD, Jiaxi Zhou, MS, Yutao Gong, PhD, Yuan Li Shen, PhD, Rajeshwari Sridhara, PhD, Albert B. Deisseroth, MD PhD, Ann T. Farrell, MD, Richard Pazdur, MD, Gideon Blumenthal, MD

Blood (2018) 132 (Supplement 1): 2670.

https://doi.org/10.1182/blood-2018-99-119678

Published: 2018

Journal Articles

FDA Analysis of Outcomes in Older Adults with Relapsed or Refractory Multiple Myeloma

Bindu Kanapuru, MD, Susan Jin, Kunthel By, Yuan Li Shen, PhD, Theresa Carioti, Nicole Gormley, MD, Ann T. Farrell, MD, Richard Pazdur, MD

Blood (2018) 132 (Supplement 1): 3287.

https://doi.org/10.1182/blood-2018-99-118597

Published: 2018

Journal Articles

Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience

Bindu Kanapuru, MD, Harpreet Singh, MD, Adrian Myers, Julia A. Beaver, MD, Virginia Elaine Kwitkowski, MS,NP, Ann T. Farrell, MD, Richard Pazdur, MD

Blood (2017) 130 (Supplement 1): 861.

https://doi.org/10.1182/blood.V130.Suppl_1.861.861

Published: 2017

Journal Articles

FDA Analysis of Racial Demographics in Multiple Myeloma Trials

Vishal Bhatnagar, MD, Nicole Gormley, MD, Dickran Kazandjian, MD, Kirsten Goldberg, MA, Amy E. McKee, MD, Gideon Blumenthal, MD, Ann T. Farrell, MD, Richard Pazdur, MD

Blood (2017) 130 (Supplement 1): 4352.

https://doi.org/10.1182/blood.V130.Suppl_1.4352.4352

Published: 2017

Journal Articles

Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs

Ann T. Farrell, Kirsten B. Goldberg, Richard Pazdur

Blood (2017) 130 (11): 1285–1289.

https://doi.org/10.1182/blood-2017-04-742726

Published: 2017

Journal Articles

Toxicity of laromustine plus high-dose cytarabine in patients with relapsed acute myeloid leukemia

Albert Deisseroth, Ann Farrell, Robert Justice, Robert Kane, Rajeshwari Sridhara, Huanyu Chen, Kun He, Richard Pazdur

Blood (2010) 115 (2): 430.

https://doi.org/10.1182/blood-2009-09-244236

Published: 2010

NARROW

Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials

Response Prediction to Isocitrate Dehydrogenase (IDH) Inhibitors in Patients with IDH1 - or IDH2 -Mutated Acute Myeloid Leukemia Using Clinical and Genomic Data

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

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

Second Cancers in Adults with Acute Promyelocytic Leukemia (APL) Treated with or without Arsenic Trioxide (ATO): A SEER-Medicare Analysis

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

FDA Analysis of Survival Outcomes in Older Adults with Relapsed-Refractory Multiple Myeloma (RRMM) Treated with Novel Drug Regimens

Developing a Genomics Model to Predict Failure of Isocitrate Dehydrogenase (IDH) Inhibitors for Treatment of Patients with IDH1- or IDH2-Mutated Acute Myeloid Leukemia

Incidence of Differentiation Syndrome with Ivosidenib (IVO) and Enasidenib (ENA) for Treatment of Patients with Relapsed or Refractory (R/R) Isocitrate Dehydrogenase (IDH)1- or IDH2-Mutated Acute Myeloid Leukemia (AML): A Systematic Analysis By the U.S. Food and Drug Administration (FDA)

Response Rate, Event-Free Survival (EFS), and Overall Survival (OS) in Newly-Diagnosed Acute Myeloid Leukemia (AML): U.S. Food and Drug Administration (FDA) Trial-Level and Patient-Level Analyses

FDA Analysis of Outcomes in Older Adults with Relapsed or Refractory Multiple Myeloma

Enrollment of Older Adults in Clinical Trials Evaluating Patients with Hematologic Malignancies - the Food and Drug Administration (FDA) Experience

FDA Analysis of Racial Demographics in Multiple Myeloma Trials

Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs

Toxicity of laromustine plus high-dose cytarabine in patients with relapsed acute myeloid leukemia

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American Society of Hematology

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American Society of Hematology

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