Posted by Michael Wonder on 21 Oct 2020
TG Therapeutics announces fast track designation granted by the FDA to ublituximab in combination with umbralisib for the treatment of adult patients with chronic lymphocytic leukaemia
21 October 2020 - TG Therapeutics today announced that the U.S. FDA has granted fast track designation to the combination of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of adult patients with chronic lymphocytic leukaemia.
Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. FDA for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma who have received at least one prior anti-CD20 based regimen or follicular lymphoma who have received at least two prior systemic therapies.
