FDA biologics license application of ublituximab plus umbralisib for the treatment of CLL

On March 29, 2021, it was announced that a biologics license application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for ublituximab in combination with umbralisib (U2) as a treatment for patients with chronic lymphocytic leukemia (CLL). The BLA submission was based on the results of the phase III UNITY-CLL trial (NCT02612311), previously published on the Lymphoma Hub, which showed a progression-free survival benefit of U2 compared with obinutuzumab plus chlorambucil for patients with treatment-naïve and relapsed/refractory CLL.¹

The U2 combination was previously granted fast track designation and orphan drug designation by the FDA for this indication.¹