A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.