Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma

The FDA has announced that it has withdrawn its approval of umbralisib (Ukoniq®, TG Therapeutics) for treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Umbralisib had previously been granted accelerated approval in February 2021 based on the UNITY-NHL trial (NCT02793583). The withdrawal of this treatment was determined due to updated data from the UNITY-CLL trial (NCT02612311), which revealed a possible increased risk of death in patients receiving umbralisib. TG Therapeuti...

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Umbralisib/Ublituximab Improves Survival in Chronic Lymphocytic Leukemia

In patients with treatment-naive or relapsed/refractory chronic lymphocytic leukemia (CLL), the combination of umbralisib and ublituximab significantly increases progression-free survival (PFS) compared with obinutuzumab/chlorambucil, according to results of a phase 3 trial recently presented at the American Society of Hematology (ASH) Annual Meeting. "Umbralisib is an oral, once-daily, novel dual inhibitor of phosphatidylinositol-3-kinase-delta (PI3Kδ) and casein kinase-1ε (CK1ε) that exhibits ...

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