Benzinga | Nov 30, 2021 04:44PM EST

TG Therapeutics Announces FDA Has Notified Co. It Plans To Host Meeting Of The Oncologic Drugs Advisory Committee In Connection To Biologics License Application For ublituximab And UKONIQ Combination

TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the U.S. Food and Drug Administration (FDA) has notified the Company that it plans to host a meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ(r) (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).



Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "We appreciate the FDA's efforts in reviewing the U2 BLA/sNDA and its interest in obtaining the perspective of the ODAC regarding the benefit-risk of UKONIQ and the U2 combination. We believe UKONIQ is a unique PI3K inhibitor, with a differentiated toxicity and tolerability profile and believe the data submitted thus far are supportive of approval of U2 in CLL."

Mr. Weiss continued, "We look forward to the ODAC meeting as we believe it will provide us an opportunity to highlight the important role U2 can play in the treatment of CLL. As we have noted previously, while many patients with CLL are well-served with currently available therapies, there exists an underserved population, which for a variety of reasons, including tolerability concerns, access issues, and treatment failure, would benefit from an alternative treatment option."