Posted by Michael Wonder on 13 Aug 2020
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
13 August 2020 - TG Therapeutics today announced that the U.S. FDA has accepted the Company’s new drug application for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma who have received at least one prior anti-CD20 based regimen and follicular lymphoma who have received at least two prior systemic therapies.
The marginal zone lymphoma indication, under breakthrough therapy designation, has been accepted for priority review and has a Prescription Drug User Fee Act goal date of 15 February 2021.
The follicular lymphoma indication has been accepted for standard review with a PDUFA goal date of 15 June 2021.
The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
