Posted by Michael Wonder on 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21.
TG Therapeutics today announced that the Company has initiated a 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 umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukaemia (CLL).
The U.S. FDA previously granted fast track designation to the combination of ublituximab and umbralisib for the treatment of adult patients with CLL and orphan drug designation covering ublituximab in combination with umbralisib for the treatment of CLL.
