Shots:

• The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 patients with treatment-naive and r/r CLL. The 1EP of the study was PFS
• The trial is being conducted under a SPA agreement with the US FDA. The FDA also notified the company that no advisory committee meeting is planned to discuss the application
• The combination therapy has previously received FTD & ODD from the FDA for the treatment of adult patients with CLL. The anticipated PDUFA date is Mar 25- 2022

  Ref: Globe Newswire | Image: TG Therapeutics