FDA Grants Fast Track Designation to LBS-007 in AML
Source: Targeted Oncology, November 2024
LBS-007, a novel targeted therapy, has received FDA fast track designation for the treatment of acute myeloid leukemia.
- The FDA granted LBS-007 fast track designation for the treatment of patients with acute myeloid leukemia (AML).
- LBS-007 is a non-ATP cell cycle inhibitor targeting a broad array of cancers.
- A phase 1/2 trial (NCT05756322) of the agent is currently being conducted in the US, Australia, and Taiwan for patients with relapsed or resistant acute leukemias.
The FDA has granted LBS-007 fast track designation for the treatment of patients with AML.1
“We are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,” said Tom Lin, MMED, PhD, MBA, chairman of Lin BioScience, in a press release. “Receiving FDA fast track designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.”