Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug application for the combination of ublituximab and Ukoniq (umbralisib) for the treatment of adult patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma.
The decision to withdraw was based on recently updated overall survival data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in overall survival.
