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# Ublituximab and Umbralisib BLA for Lymphocytic Leukemia
- URL: https://www.fdaweb.com/ublituximab-and-umbralisib-bla-for-lymphocytic-leukemia/
- Published: 2020-12-03T12:00:00.000Z
- Updated: 2026-09-14T16:38:49.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148228

TG Therapeutics has begun a rolling BLA submission for ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia. The submission is based on data from the UNITY-CLL Phase 3 trial which the company says met its primary endpoint of improvement in progression-free survival compared to obinutuzumab plus chlorambucil. Earlier this year, FDA accepted two NDAs for umbralisib for treating patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). FDA granted a user fee goal date of 2/15/2021 for MZL and 6/15/2021 for FL.