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Investigational treatment will target marginal zone lymphoma (MZL) and follicular lymphoma (FL).
TG Therapeutics completed the rolling submission of a New Drug Application (NDA) to FDA, requesting accelerated approval of umbralisib to treat certain types of lymphoma.
The investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon will treat patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).
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FDA previously granted umbralisib breakthrough therapy designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.
"The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment option for patients with relapsed/refractory MZL and FL,” said Michael S. Weiss, TG Therapeutics’ executive chairman and CEO in a press release.
TG Therapeutics is evaluating umbralisib in the UNITY-NHL trial , a multicenter, open-label Phase 2b trial.
In February 2019, the company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the company’s target guidance of 40-50% ORR.