TG Therapeutics granted FDA Fast Track Designation for Ublituximab+Umbralisib in CLL

The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that had met its primary endpoint of progression free survival, as announced in May 2020. This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL. The data from the UNITY-CLL Phase 3 trial will be presented later this year, which the company plans to use as the basis of a U2 regulatory submission for CLL. The UNITY-CLL Phase 3 trial is being conducted under Special Protocol Assessment (SPA) agreement with the U.S. FDA. 


Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.