FDA grants fast track designation to ublituximab plus umbralisib for CLL
The FDA granted fast track designation to the combination of ublituximab and umbralisib for the treatment of adults with chronic lymphocytic leukemia, according to a press release from the drugs’ manufacturer.
Ublituximab (TG-1101, TG Therapeutics) is a glycoengineered monoclonal antibody that targets a specific epitope on the CD20 antigen found on mature B lymphocytes, and umbralisib (TGR-1202, TG Therapeutics) is a dual inhibitor of PI3 kinase-delta and CK1-epsilon.
Researchers of the phase 3 randomized controlled UNITY-CLL trial compared the combination with a control regimen of obinutuzumab (Gazyva, Genentech/Roche) plus chlorambucil among 420 adults with treatment-naive (60%) or relapsed/refractory (40%) CLL.
In May, topline data released by the company showed the study met its primary endpoint of PFS.
“We are extremely pleased to have received fast track designation for the ublituximab-plus-umbralisib regimen, or the U2 combination, to treat adult patients with CLL,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in the press release. “This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL. We look forward to presenting data from the UNITY-CLL phase 3 trial later this year, which we plan to use as the basis of a U2 regulatory submission for CLL.”
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