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The FDA announced that it has withdrawn approval for umbralisib (Ukoniq, TG Therapeutics), based on an updated analysis of the phase 3 UNITY-CLL clinical trial, which continues to show “a possible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.
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 patients with MZL and FL—it was part of a supplemental application seeking approval to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)—“we believe [the elevated mortality risk in the trial has] implications for its approved uses,” the FDA stated. “In addition, clinical trials of other medicines in the same PI3 kinase inhibitor class as Ukoniq have shown similar safety concerns.”
The FDA announcement is not the first to cite safety concerns related to umbralisib. On April 15, 2022, TG Therapeutics issued a statement noting that it was withdrawing its application for the CLL and SLL indications, based on updated data on overall survival (OS) from the UNITY-CLL trial. Those data “showed an increasing [survival] imbalance in favor of the control arm, differing from the improved results provided to the FDA” in an earlier data submission, the company noted.
The April announcement from TG Therapeutics followed a February statement from the FDA which noted that the agency was investigating the elevated mortality risk in the UNITY trial.
The FDA has instructed healthcare professionals to stop prescribing umbralisib and to switch patients to alternative treatments. Additionally, patients who are currently taking the medication should be “informed of the increased risk of death seen in the clinical trial” and advised to stop taking the medicine.
“In limited circumstances in which a patient may be receiving benefit from Ukoniq, TG Therapeutics plans to make it available under expanded access,” the agency added.
The FDA also urged healthcare professionals and patients to report side effects of umbralisib to the FDA MedWatch program.
JUNE 2, 2022
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