Umbralisib, a dual inhibitor of PI3 kinase-delta and CK1-epsilon, was approved in February 2021 to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Although UNITY-CLL did not include
JUNE 3, 2022
FDA Withdraws Umbralisib Due to Elevated Mortality Risk
The FDA announced that it has withdrawn approval for umbralisib (Ukoniq, TG Therapeutics), based on an updated analysis of the phase 3 UNITY-CLL clinical trial, which continues to show “a possible increased risk of death” in patients receiving the medication, the agency noted.