General AML,   FLT3

FDA lifts clinical hold on the phase I/II trial of SEL24 in AML

Last month, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the phase I/II clinical trial of SEL24, a first-in-class dual PIM/Fms like tyrosine kinase (FLT3) inhibitor, in patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML). The aim of the study was to determine the maximum tolerated dose (MTD), safety and  anti-leukemic activity of SEL24 in R/R AML patients.

In October 2017, the AML Global Portal (AGP) reported on the clinical hold placed on the phase I/II trial of SEL24 by the FDA after the drug manufacturer’s, Selvita reported a grade 4 adverse reaction of a fatal stroke in a patient receiving the 150 mg dose of SEL24 in the dose escalation phase of the study.

The FDA agreed to lift the clinical hold on Selvita’s trial if they revise the dose-finding scheme to a standard ‘3+3 design’ under an amended protocol based on the recommendations of the FDA. Selvita says that they “will be working closely with the investigators and clinical sites to obtain IRB’s approval on the revised protocols and resume patient enrolment.”

References
  1. Selvita: FDA lifts Clinical Hold on Selvita’s Phase I/II Clinical Trial with SEL24 in AML. 2017 Dec 16. https://selvita.com/news/fda-lifts-clinical-hold-on-selvitas-phase-iii-clinical-trial-with-sel24-in-aml/. [Accessed 2018 Jan 3].