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FDA biologics license application of ublituximab plus umbralisib for the treatment of CLL

Mar 30, 2021
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On March 29, 2021, it was announced that a biologics license application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for ublituximab in combination with umbralisib (U2) as a treatment for patients with chronic lymphocytic leukemia (CLL). The BLA submission was based on the results of the phase III UNITY-CLL trial (NCT02612311), previously published on the Lymphoma Hub, which showed a progression-free survival benefit of U2 compared with obinutuzumab plus chlorambucil for patients with treatment-naïve and relapsed/refractory CLL.1

The U2 combination was previously granted fast track designation and orphan drug designation by the FDA for this indication.1

  1. TG Therapeutics. TG Therapeutics completes rolling submission of biologics license application to the U.S. Food and Drug Administration for ublituximab in combination with UKONIQ™(umbralisib) as a treatment for patients with chronic lymphocytic leukemia. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-completes-rolling-submission-biologics-license. Published Mar 29, 2021. Accessed Mar 30, 2021

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