Pharma Focus Asia

TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Follicular Lymphoma

Friday, March 06, 2020

TG Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma (FL).

Umbralisib is being evaluated across several types of lymphoma in the UNITY-NHL Phase 2b registration directed clinical trial. The FL cohort of the UNITY-NHL trial is designed to evaluate the safety and efficacy of umbralisib in patients with FL who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. In October 2019, the Company announced that the FL cohort met the primary endpoint of overall response rate (ORR), and in January the Company initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and FL.

The FDA has previously granted orphan drug designation to umbralisib, for the treatment of patients with all three types of MZL: nodal, extranodal, and splenic MZL.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics, stated, “The receipt of orphan drug designation for umbralisib to treat patients with FL is another important milestone in the development and anticipated commercialization of umbralisib in MZL and FL.”  Mr. Weiss continued, “We were pleased to announce last year that both the MZL and FL cohorts of the UNITY-NHL trial met their primary endpoints and have commenced our first rolling submission for these indications. We are excited by the progress so far and look forward to completion of this submission targeted in the first half of this year.”

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