The company expects to complete the rolling submission of its biologics license application for ublituximab in combination with umbralisib in the first half of 2021.
TG Therapeutics, Inc. requested approval of ublituximab in combination with umbralisib (TGR-1202) to treat patients with chronic lymphocytic leukemia (CLL).
The company expects to complete the rolling submission of its biologics license application (BLA) in the first half of 2021.
“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,” Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics, said in a press release, adding that the BLA is supported by the phase 3 UNITY-CLL trial.
The global, randomized, controlled trial, which will be presented at the 2020 American Society of Hematology (ASH) annual meeting, met its primary end point of progression-free survival with the combination regimen, compared with Obinutuzumab (Gazyva) plus chlorambucil, in patients with both treatment-naïve and relapsed or refractory CLL.
The trial randomized patients into 4 treatment arms:
Of the 420 patients enrolled in the 2 combination arms, approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory.
Progression-free survival in the ublituximab plus umbralisib arm served as the primary end points of the study. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment agreement with the FDA.
“I want to thank the patients, caregivers and research teams who participated in our clinical trials and helped to advance (ublituximab in combination with umbralisib) to this stage. We believe, if approved, (the combination) has the potential to become an important treatment option to both front line and relapsed/refractory patients with CLL,” Weiss added.
The FDA previously granted fast track designation and orphan drug designation to the combination of ublituximab and umbralisib for the treatment of adult patients with CLL. TG Therapeutics, Inc.
TG Therapeutics, Inc. TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia. Published: December 1, 2020. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-initiates-rolling-submission-biologics-license. Accessed: December 1, 2020.