TG Therapeutics announced that the FDA granted orphan drug designation to its-3-kinase, or PI3K, delta inhibitor, umbralisib, for the treatment of patients with all three types of marginal zone lymphoma, or MZL Umbralisib monotherapy is being evaluated in the UNITY-NHL Phase 2b registration directed clinical trial. The MZL cohort of the UNITY-NHL trial is currently evaluating the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen, the same indication for which the FDA recently granted breakthrough therapy designation for umbralisib.
https://thefly.com/landingPageNews.php?id=2892411
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