Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia

Daniel A Pollyea; John Barrett; Courtney D DiNardo; Laura C Michaelis; Gail J Roboz; Robert Q Le; Kelly J Norsworthy; R Angelo de Claro; Marc R Theoret; Richard Pazdur

doi:10.1158/1078-0432.CCR-21-2124

Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia

Clin Cancer Res. 2022 Mar 1;28(5):816-820. doi: 10.1158/1078-0432.CCR-21-2124.

Authors

Affiliations

¹ Division of Hematology, University of Colorado School of Medicine, Aurora, Colorado.
² George Washington Cancer Center, GW School of Medicine and Health Sciences, Washington, DC.
³ Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
⁴ Medical College of Wisconsin, Milwaukee, Wisconsin.
⁵ Weill Cornell Medical College and the New York Presbyterian Hospital, New York, New York.
⁶ Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC.
⁷ Oncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC.

PMID: 34753779
DOI: 10.1158/1078-0432.CCR-21-2124

Abstract

The Food and Drug Administration Oncology Center of Excellence initiated Project 2025 to develop 5-year goals in specific areas of oncology drug development. This meeting, in October 2020, brought together a panel of regulators and academic experts in acute myeloid leukemia (AML) to discuss opportunities to maximize the success that has recently occurred in AML drug development. The panel discussed challenges and opportunities in clinical trial design and novel endpoints, and outlined key considerations for drug development to facilitate continued growth in the field.

MeSH terms

Drug Development
Humans
Leukemia, Myeloid, Acute* / drug therapy
United States
United States Food and Drug Administration