TG Therapeutics, Inc. Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma
January 22, 2019 at 08:08 am EST
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TG Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for umbralisib (TGR-1202) for the treatment of adultpatients with marginal zone lymphoma (MZL) who have received at leastone 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. Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officerstated, the company look forward to working closely with the FDA to bring umbralisib, its novelPI3K-delta inhibitor to patients as quickly as possible. MZL patients who fail initial chemo-immunotherapy are left with limited treatment options. The company believe umbralisib can play an important role in fulfilling this unmet medical need. The MZL single agent umbralisib cohort of the UNITY-NHL study is fully enrolled and the company look forward to reporting top-line results from this cohort by mid-year and presenting the data at a major medical meeting in 2019. The FDAs Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies. Marginal 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 B-cell NHL accounting for approximately eight percent of all NHL cases.i MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).
TG Therapeutics, Inc. is a fully integrated, commercial stage, biopharmaceutical company. The Company is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. Its clinical drug candidates include Ublituximab (anti-CD20 mAb), TG-1701 (BTK inhibitor) and TG-1801 (anti-CD47/CD19 bispecific mAb). BRIUMVI is an anti-CD20 monoclonal antibody for the treatment of RMS, which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TG-1701 is a novel, orally available and covalently bound Brutonâs tyrosine kinase (BTK) inhibitor that exhibits selectivity to BTK in in vitro kinase screening. TG-1801 is a bispecific CD47 and CD19 antibody. It is the therapy to target both CD19, a B-cell specific market expressed across B-cell malignancies, and CD47. It also evaluates complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
TG Therapeutics, Inc. Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Umbralisib for the Treatment of Marginal Zone Lymphoma
TG THERAPEUTICS, INC. 
