-Author name in bold denotes the presenting author
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ASH-FDA Joint Symposium II: Striking a Balance - Benefit-Risk in Drug Approvals

Program: Special-Interest Sessions
Hematology Disease Topics & Pathways:
Therapies
Monday, December 11, 2023: 2:45 PM-4:15 PM
Marriott Grand Ballroom 5-6 (Marriott Marquis San Diego Marina)
Chair:
Cara Rabik, MD, PhD, Food and Drug Administration
Disclosures:
No relevant conflicts of interest to declare.
Introduction

Cara Rabik, MD, PhD

DHM1/CDER, Food and Drug Administration, Silver Spring, MD
Regulatory Considerations - Recent Approvals of Bispecific T Cell Engagers for Lymphoma - Epcoritamab-bysp and Glofitamab-gxbm

Nicole Sunseri, MD, PhD

DHM2/CDER, Food and Drug Administration, Silver Spring, MD
Regulatory Considerations - Recent Approvals of Bispecific T Cell Engagers for Multiple Myeloma - Talquetamab-tgvs and Elranatamab-bcmm

Nicole Sunseri, MD, PhD

DHM2/CDER, Food and Drug Administration, Silver Spring, MD
Clinical Discussant for Lymphoid Malignancies

Jeff P. Sharman, MD

Willamette Valley Cancer Institute and Research Center, Eugene, OR
Quizartinib for Acute Myeloid Leukemia

Joseph Wynne, MD, PhD

DHM1/CDER, Food and Drug Administration, Silver Spring, MD
Clinical Discussant for Acute Myeloid Leukemia

Alice Mims, MD

Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, OH
Overall Survival: Striking a Balance - Benefit-Risk in Drug Approvals

Margret Merino, MD

DHM2/CDER, Food and Drug Administration, Silver Spring, MD
Panel Discussion

Cara Rabik, MD, PhD

DHM1/CDER, Food and Drug Administration, Silver Spring, MD
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