Umbralisib orphan drug for follicular lymphomaApril 4, 2020
The USFDA has granted orphan drug designation to umbralisib for the treatment of patients with follicular lymphoma (FL), TG Therapeutics announced.
Umbralisib is a dual inhibitor of PI3K-delta and CK1-epsilon.
The drug is being evaluated across several types of lymphoma in the UNITY-NHL phase 2b registration directed clinical trial.
The FL cohort of the UNITY-NHL trial is designed to evaluate the safety and efficacy of umbralisib in patients with FL who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent.
In October 2019, the company announced that the FL cohort met the primary endpoint of overall response rate (ORR), and in January the company initiated a rolling submission of a New Drug Application (NDA) to the US FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma (MZL) and FL..