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TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for ublituximab and Ukoniq combination to treat patients with CLL and SLL.

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Published:19th Apr 2022

TG Therapeutics, Inc. announced that the Company has voluntarily withdrawn the pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA) for the combination of ublituximab and Ukoniq (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The decision to withdraw was based on recently updated overall survival (OS) data from the UNITY-CLL Phase III trial that showed an increasing imbalance in OS.

In addition, the Company announced that it has voluntarily withdrawn Ukoniq from sale for the approved indications of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with follicular lymphoma (FL) who have received at least three prior systemic therapies. Ukoniq was granted accelerated approval in these indications in February 2021. The Company’s decision to withdraw Ukoniq from sale was primarily based on the withdrawal of the BLA and sNDA for U2 in CLL.

Condition: CLL/SLL
Type: drug

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