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TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting
FDA schedules ODAC meeting for April 22, 2022 NEW YORK, March 10, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"FDA schedules ODAC meeting for April 22, 2022\nNEW YORK, March 10, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the U.S. Food and Drug Administration (FDA) has set a date of April 22, 2022 for the previously announced meeting of the Oncologic Drugs Advisory Committee (ODAC) in connection with its review of the Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and UKONIQ® (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. The Company previously announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date to June 25, 2022 for the BLA/sNDA for U2 to treat CLL and SLL. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “As noted on our recent year-end call, the team, as well as our external consultants, have been working hard to prepare and we look forward to sharing the data with everyone during the ODAC meeting.” ABOUT THE ODAC MEETINGIn general, the Oncologic Drugs Advisory Committee (ODAC) reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the ODAC Committee, the final decision regarding the approval of a product is made solely by the FDA. The FDA has notified the Company that potential questions and discussion topics for the ODAC include: the benefit-risk of the U2 combination in the treatment of CLL or SLL, and the benefit-risk of UKONIQ in relapsed/refractory marginal zone lymphoma (MZL) or follicular lymphoma (FL). In addition, as part of the benefit-risk analysis, the overall safety profile of the U2 regimen, including adverse events (serious and Grade 3-4), discontinuations due to adverse events, and dose modifications, is expected to be reviewed. The FDA’s concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial. Overal...