TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
Aug 13, 2020
The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Company’s target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.
ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.
The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL
The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 7,500 newly diagnosed patients in
ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the
12016 Lymphoid Malignancy Statistics by World Health Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER 2016 https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.21357
3 American Cancer Society “Key Statistics for Non-Hodgkin Lymphoma”
4 Lymphoma Research Foundation “Follicular Lymphoma”
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following: the risk that umbralisib may not receive regulatory approval for previously treated MZL or FL in the currently anticipated timeline or at all; the risk that the FDA may grant approval that is more restrictive than anticipated; our ability to successfully launch umbralisib for previously treated MZL or FL, if those indications are approved by the FDA; our ability to successfully and cost-effectively complete our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), which may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; and the risk that the COVID-19 pandemic causes unforeseen delays in the FDA timelines we have outlined or in our ability to achieve other milestones we project. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Senior Vice President,
Source: TG Therapeutics, Inc.