Ublituximab + umbralisib granted FDA fast track designation for the treatment of CLL

Ublituximab in combination with umbralisib (U2) has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

The decision follows positive data from the phase III UNITY-CLL trial comparing U2 to obinutuzumab + chlorambucil in patients with treatment-naïve and relapsed and/or refractory (R/R) chronic CLL, which met its primary endpoint in May 2020.

U2

The U2 combination regimen comprises the investigational, anti-CD20 monoclonal antibody, ublituximab, and the investigational, once-daily, oral inhibitor of PI3K-delta and CK1-epsilon, umbralisib.