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TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma
TG received guidance from the FDA allowing submission of a single NDA for Marginal Zone Lymphoma (MZL) and Follicular Lymphoma indications Completion of
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"TG received guidance from the FDA allowing submission of a single NDA for Marginal Zone Lymphoma (MZL) and Follicular Lymphoma indications\n Completion of rolling submission for the MZL/FL NDA expected in 1H20 NEW YORK, Jan. 16, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, announced that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The Company has received guidance from the FDA that submission of a single NDA for both the MZL and FL indications is acceptable. Umbralisib has previously been granted both orphan drug designation and breakthrough therapy designation by the FDA for MZL. The Company expects to complete the NDA rolling submission in the first half of 2020. Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are extremely pleased to have initiated our first NDA submission for umbralisib and to have received guidance from the FDA to include both MZL and FL in a single NDA. This is an extremely important milestone for us, as it brings us one step closer to potentially offering a novel treatment option to patients with previously treated MZL and FL.” Mr. Weiss continued, “I want to thank the patients, their families and the research teams who participated in these important trials and helped advance umbralisib, and the TG team for working tirelessly to initiate this NDA submission. This is the beginning of an impactful 2020 as we look forward to topline Phase 3 data from both the UNITY-CLL trial and the ULTIMATE I & II trials in multiple sclerosis, as well as potential regulatory submissions based off these data.” ABOUT THE UNITY-NHL PHASE 2b STUDY—MARGINAL ZONE LYMPHOMA AND FOLLICULAR LYMPHOMA COHORTS The UNITY- NHL trial is a multicenter, open-label Phase 2b trial. The Marginal Zone Lymphoma (MZL) cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. Th...