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Special Seminar: Regulation of Targeted Therapies for Patients with Myeloid Malignancies

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Kelly Norsworthy, M.D.

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
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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.

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