Posted by Michael Wonder on 29 Mar 2021
TG Therapeutics completes rolling submission of biologics license application to the U.S. FDA for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia
29 March 2021 - TG Therapeutics today announced the completion of the rolling submission of a biologics license application to the U.S. FDA requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib) , the Company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukaemia.
The U.S. FDA previously granted fast track designation to the combination of ublituximab and umbralisib for the treatment of adult patients with chronic lymphocytic leukaemia and orphan drug designation for ublituximab in combination with umbralisib for the treatment of chronic lymphocytic leukaemia.
The submission was based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of umbralisib plus ublituximab compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia.
