2020-12-01 07:09:47 TGTX TG Therapeutics
12/01/20 12/0107:09 12/01/2007:09 | TG Therapeutics initiates rolling submission of BLA for ublituximab/umbralisibTG Therapeutics announced that the Company has initiated a rolling submission of a Biologics License Application to the U.S. Food and Drug Administration requesting approval of ublituximab, the Company's investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Company's investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia. The U.S. FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib for the treatment of adult patients with CLL and Orphan Drug Designation covering ublituximab in combination with umbralisib for the treatment of CLL. The Company expects to complete the BLA rolling submission in the first half of 2021. The Company has previously submitted a New Drug Application to the FDA for umbralisib to treat relapsed/refractory marginal zone lymphoma and follicular lymphoma and the FDA has granted Prescription Drug User Fee Act goal dates of February 15, 2021 for MZL and June 15, 2021 for FL. |
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