Special Seminar: Regulation of Targeted Therapies for Patients with Myeloid Malignancies
Kelly Norsworthy, M.D.
Director
Division of Hematologic Malignancies I
Office of Oncologic Diseases, Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Regulation of Targeted Therapies for Patients with Myeloid Malignancies
Date: April 23, 2026
Time: 2 p.m.
Collaboratory, 3rd Floor, Children’s National Research and Innovation Campus
About this Seminar
Dr. Norsworthy will discuss FDA's regulation of targeted therapies for myeloid malignancies, focusing on drug approvals for genetically defined biomarker subsets. She will cover FDA approval requirements and clinical endpoints for acute myeloid leukemia, myelodysplastic syndromes, and chronic myeloid leukemia. Her presentation will highlight how biomarkers are integrated throughout drug development—from early discovery to pivotal trials and regulatory approval.