Posted by Michael Wonder on 18 Jun 2020
TG Therapeutics completes rolling submission of new drug application to the U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
17 June 2020 - TG Therapeutics today announced the completion of the rolling submission of a new drug application to the U.S. FDA requesting accelerated approval of 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 and follicular lymphoma.
The FDA previously granted umbralisib breakthrough therapy designation for marginal zone lymphoma and orphan drug designation for marginal zone lymphoma and follicular lymphoma.
