FDA Grants Umbralisib Breakthrough Designation for Marginal Zone Lymphoma

January 22, 2019 – The FDA has granted umbralisib (TGR-1202) a breakthrough therapy designation for the treatment of adult patients with marginal zone lymphoma (MZL) who have received 1 prior anti-CD20 regimen, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor. The designation is based on interim data from a cohort of the ongoing, registration-directed phase II UNITY-NHL trial that is evaluating umbralisib monotherapy in … (leggi tutto)