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2024-11-27T15:49:09.000Z

U.S. FDA grants fast track designation to cell cycle inhibitor LBS-007

Nov 27, 2024
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Learning objective: After reading this article, learners will be able to cite a new development in the treatment of acute lymphoblastic leukemia.

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On November 27, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to LBS-007, a natural non-ATP cell cycle inhibitor, which is in development for the treatment of patients with relapsed/resistant (R/R) acute leukemias.1 It previously received orphan drug designation by the U.S. FDA on April 24, 2018, for the treatment of acute lymphoblastic leukemia (ALL).2

LBS-007 inhibits the kinase activity of cell division cycle 7 (CDC7), which regulates the cancer cell cycle, thereby disrupting tumor cell proliferation and triggering cancer cell death. Its potent anti-leukemia activity has been demonstrated in preclinical studies.1 Currently, an open-label, multicenter, phase I/II trial (NCT05756322) is ongoing to investigate the safety, tolerability, and maximum tolerated dose of LBS-007 in patients with acute leukemias.3

  1. GlobeNewswire. Lin BioScience receives U.S. FDA fast track designation for LBS-007. https://www.globenewswire.com/news-release/2024/11/27/2987977/0/en/Lin-BioScience-Receives-U-S-FDA-Fast-Track-Designation-For-LBS-007.html. Published Nov 27, 2024. Accessed Nov 27, 2024.
  2. PRNewswire. Lin BioScience announces FDA orphan drug designation for LBS-007 for the treatment of acute lymphoblastic Leukemia. https://www.prnewswire.com/news-releases/lin-bioscience-announces-fda-orphan-drug-designation-for-lbs-007-for-the-treatment-of-acute-lymphoblastic-leukemia-300635205.html. Published Apr 24, 2018. Accessed Nov 27, 2024.
  3. ClinicalTrials.gov. The safety and tolerability of LBS-007 in patients with relapsed or resistant acute leukaemias. https://clinicaltrials.gov/study/NCT05756322?intr=LBS-007&rank=1. Updated Oct 15, 2024. Accessed Nov 27, 2024.

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