Posted by Michael Wonder on 16 Jan 2020
TG Therapeutics initiates rolling submission of new drug application to U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
16 January 2020 - Completion of rolling submission for the MZL/FL NDA expected in 1H20.
TG Therapeutics announced that the Company has initiated a rolling submission of a new drug application to the U.S. FDA requesting accelerated approval of umbralisib, the Company’s oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).
The Company has received guidance from the FDA that submission of a single NDA for both the MZL and FL indications is acceptable. Umbralisib has previously been granted both orphan drug designation and breakthrough therapy designation by the FDA for MZL.
