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

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.

• Authors: 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
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 28 Issue 5 Pg. 816-820 (03 01 2022) ISSN: 1557-3265 [Electronic] United States
• PMID: 34753779 (Publication Type: Journal Article)
• Copyright: ©2021 American Association for Cancer Research.

Topics

• Drug Development
• Humans
• Leukemia, Myeloid, Acute (drug therapy)
• United States
• United States Food and Drug Administration