TG Therapeutics rolling U.S. application for leukemia doublet therapy

 

• TG Therapeutics (NASDAQ:TGTX) initiates its rolling U.S. marketing application seeking approval of ublituximab, combined with umbralisib, for the treatment of chronic lymphocytic leukemia (CLL), a Fast Track- and Orphan Drug-tagged indication. The company expects to complete the filing in H1 2021.
• Ublituximab is an anti-CD20 monoclonal antibody. Umbralisib is a dual inhibitor of enzymes PI3K-delta and CK1-epsilon. The company calls the doublet therapy "U2."
• Its U.S. marketing applications for umbralisib for marginal zone lymphoma and follicular lymphoma are currently under FDA review with action dates of February 14, 2021 and June 15, 2021, respectively.
• https://seekingalpha.com/news/3640326-tg-therapeutics-commences-rolling-u-s-application-for-doublet-therapy-for-cll