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TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its phosphoinositide-3-kinase (PI3K) delta inhibitor, umbralisib (TGR-1202), for the treatment of patients with all three types of marginal zone lymphoma (MZL): nodal, extranodal, and splenic 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.Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated \"Receiving orphan drug designation for umbralisib in patients with MZL is another important milestone in our commitment to developing novel treatment options for patients with B-cell malignancies, including orphan diseases such as MZL.\" Mr. Weiss continued, \"We are highly encouraged by the interim results presented thus far for the MZL cohort of the UNITY-NHL trial and we look forward to presenting final data from this cohort later this year and to discussing the results with the FDA with the goal of filing for accelerated approval of umbralisib by year-end.\"ABOUT ORPHAN DRUG DESIGNATIONOrphan drug designation is granted by the U.S. FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.ABOUT MARGINAL ZONE LYMPHOMAMarginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients, MZL is the third most common ...