Elacyt (Clavis Pharma) gets FDA fast track status for AML

Clavis Pharma announced that the FDA had granted fast track status to Elacyt(elacytarabine) for acute myeloid leukemia (AML). Elacytarabine is currently being evaluated in a randomised Phase III trial (known as the CLAVELA study) comparing it with the investigator's choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes). The primary objective of the study is to compare overall survival between patients treated with elacytarabine and those treated with investigator's choice. Clavis Pharma are based in Oslo, Norway.