TG Therapeutics Reports the US FDA’s Acceptance of BLA for Ublituximab + Ukoniq (umbralisib) to Treat Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

May 26, 2021 Auto Bot BLA, FDA, regulatory, TG Therapeutics 0

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

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: TG Therapeutics

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