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

Daniel A Pollyea1, John Barrett2, Courtney D DiNardo3

  • 1Division of Hematology, University of Colorado School of Medicine, Aurora, Colorado.

Insights

Project 2025 aims to advance acute myeloid leukemia (AML) drug development by addressing clinical trial design and novel endpoints. Experts convened to outline strategies for continued growth in AML therapeutics.

Area of Science:

  • Oncology
  • Hematology
  • Drug Development

Background:

  • The Food and Drug Administration Oncology Center of Excellence launched Project 2025.
  • Recent successes in acute myeloid leukemia (AML) drug development necessitate strategic planning.

Purpose of the Study:

  • To establish 5-year goals for oncology drug development, focusing on AML.
  • To identify challenges and opportunities in AML clinical trial design and novel endpoints.

Main Methods:

  • Convened a panel of regulators and academic experts in October 2020.
  • Facilitated discussions on optimizing AML drug development strategies.

Main Results:

  • Identified key considerations for advancing AML drug development.
  • Outlined opportunities to maximize recent successes in the field.

Conclusions:

  • Strategic planning is crucial for continued growth in AML therapeutics.
  • Addressing clinical trial design and endpoints will enhance drug development success.

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