FDA suspends clinical trials of Selvita’s leukemia drug

The Food and Drug Administration (FDA) ordered the suspension of clinical trials of the WSE-listed Selvita’s leukemia drug Sel24 following the patient’s death. The victim died following a stroke which was reported as “suspected serious unexpected adverse reaction” which according to the doctors conducting the study could “possibly be linked with the drug's usage.” Selvita announced that it will work closely with FDA to resume the tests as soon as possible by providing additional data and introducing amendments in trial protocols. SEL24 is first-in-class dual PIM/FLT3 kinase inhibitor with a unique activity profile in oral formulation. It is intended for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML).