Posted by Michael Wonder on 23 Jan 2019
TG Therapeutics receives breakthrough therapy designation from the U.S. FDA for umbralisib for the treatment of marginal zone lymphoma
22 January 2019 - Breakthrough therapy designation granted based on interim data from the marginal zone lymphoma cohort of the UNITY-NHL trial.
TG Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for umbralisib (TGR-1202) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 regimen. There are currently no fully approved agents for MZL.
The breakthrough therapy designation was based on interim data from the MZL cohort evaluating umbralisib monotherapy in the ongoing UNITY-NHL Phase 2b registration-directed clinical trial.
