From the beginning, TG Therapeutics Inc common stock (NASDAQ:TGTX) has always had big dreams of challenging the status quo of drug development. Over the years, the company has evolved and remained true to its original goal of creating the best possible treatment options for B-cell disease patients. Today, its New Drug Application (NDA) for umbralisib has been accepted by the FDA, a move, which would not have come at a better time than now.
Umbralisib is detailed as a treatment for patients with previously treated marginal zone lymphoma (MZL). The oral and investigational dual inhibitor of PI3K-delta and CK1-epsilon is administered once daily to patients who must have received at least two prior systemic therapies.
The UNITY-NHL Phase 2b Trial Data Supporting the NDA Submission
‘’… This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases,’’ Michael S. Weiss, the CEO of TG Therapeutics commented.
The NDA data for umbralisib resulted from a UNITY-NHL trial, which included the umbralisib monotherapy MZL and FL cohorts. The basis was an evaluation of patients with relapsed/refractory MZL or FL. MZL was evaluating the safety and efficacy of single-agent umbralisib in patients with MZL while FL was evaluating the safety and efficacy of single-agent umbralisib in patients with FL but had relapsed on at least two lines of therapy.
TG Therapeutics says it is preparing to present the trial data by the end of the year. Its approval will avail a treatment option for patients with previously treated MZL and FL.
Umbralisib Previously Granted Breakthrough Therapy Designation (BTD)
Each year, the United States reports close to 7,500 newly diagnosed cases of MZL. It is the third most common B-cell NHL, considerably chronic and incurable. The FDA has previously granted umbralisib Breakthrough Therapy Designation (BTD) and orphan drug designation (ODD) for MZL.
Meanwhile, the company has continued to dedicate itself to studying the concepts associated with B-cells and B-cell diseases. It has been conducting researches, and on each research, there is some puzzle to undo. Currently, TG says it has five unique medicines under development in 40 clinical trials and anticipation of four approvals in the 2020-2021 timeframe.