Jan. 16, 2020: TG Therapeutics, Inc. announced that the Company has been initiating a rolling submission of a New Drug Application (NDA) to the U.S. FDA requesting accelerated approval of umbralisib, oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for the patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).
The Company has received guidance from the FDA that the submission of a single NDA for both the MZL and FL indications is acceptable. Umbralisib has earlier been granted both orphan drug designation and breakthrough therapy designation by the FDA for MZL.
The Company expects to complete the NDA rolling submission with the first half of 2020.The UNITY- NHL trial is the multicenter, open-label Phase 2b trial.
The Marginal Zone Lymphoma (MZL) cohort was designed in order to evaluate the safety and efficacy of single agent umbralisib, in the patients with MZL who have received at least one prior anti-CD20 regimen.
The primary endpoint is overall response rate (ORR) as determined by the central Independent Review Committee (IRC) assessment.
The Follicular Lymphoma (FL) cohort was designed in order to evaluate the safety and efficacy of single agent umbralisib in the patients with FL who have received at least two prior lines of the therapy, including an anti-CD20 regimen and an alkylating agent.
The primary endpoint is overall response rate (ORR) as determined by the Independent Review Committee (IRC) assessment. https://fda.einnews.com/pr_news/507319196/tg-therapeutics-initiates-rolling-submission-of-new-drug-application-nda-to-u-s-food-and-drug-administration-for-umbralisib-as-a-treatment-for