FDA grants Fast Track Designation to ublituximab in combination with umbralisib for treatment of chronic lymphocytic leukaemia

Application for Fast Track Designation for ublituximab, a glycoengineered anti-CD20 monoclonal antibody, and umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon, was based on data from UNITY-CLL phase 3 study(n=420) that met primary endpoint of progression free survival.

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Biospace Inc.