Benzinga | Dec 1, 2020 07:04AM EST

TG Therapeutics Initiates Rolling Submission Of Biologics License Application To FDA For Ublituximab In Combination With Umbralisib As A Treatment For Patients With Chronic Lymphocytic Leukemia

Completion of rolling submission for the BLA expected in 1H21



NDA for umbralisib monotherapy currently under review with the FDA; PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL



NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that the Company has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (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 leukemia (CLL). The U.S. FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and Orphan Drug Designation (ODD) covering ublituximab in combination with umbralisib for the treatment of CLL. The Company expects to complete the BLA rolling submission in the first half of 2021.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "The initiation of a BLA submission for ublituximab in combination with umbralisib is an important milestone for us, and one that brings us one step closer to our goal of developing combination therapies for patients in need. This application, as well as the recently granted Fast Track Designation, is supported by the UNITY-CLL Phase 3 trial which met its primary endpoint of improvement in progression-free survival compared to obinutuzumab plus chlorambucil and will be presented in an oral presentation at the 2020 American Society of Hematology (ASH) annual meeting beginning this weekend." Mr. Weiss continued, "I want to thank the patients, caregivers and research teams who participated in our clinical trials and helped to advance the U2 combination to this stage. We believe, if approved, U2 has the potential to become an important treatment option to both front line and relapsed/refractory patients with CLL."



The Company has previously submitted a New Drug Application (NDA) to the FDA for umbralisib to treat relapsed/refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) and the FDA has granted Prescription Drug User Fee Act (PDUFA) goal dates of February 15, 2021 for MZL and June 15, 2021 for FL.