FDA Grants Fast Track Designation to Ublituximab Plus Umbralisib in Chronic Lymphocytic Leukemia

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With this fast track designation, the combination of ublituximab and umbralisib should move through the FDA’s approval process more quickly, and this offer CLL patients, more treatment options. Ublituximab is potent monoclonal antibody targeting CD20 similar to obinutizumab. Umbralisib is a new PI3K inhibitor that may have a different and more benign side effect profile than the approved drugs, idelalisib and duvelisib. Here is the link to TG Therapeutic’s press release.