FDA Accepts TG Theraputics NDA for Lymphoma

FDA has accepted a TG Therapeutics NDA for umbralisib, a once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma who have received at least one prior anti-CD20 based regimen and patients with follicular lymphoma who have received at least two prior systemic therapies. The agency has set a 2/15/2021 user fee review action target date. FDA previously granted umbralisib a breakthrough therapy designation and an orphan drug designation for marginal zone lymphoma and an orphan drug designation for follicular lymphoma.

The submission was based on data from the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma. The company says that each cohort met its primary endpoint of 40-50% overall response rate, as confirmed by an independent review committee.