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# FDA Looking at Ukoniq Death Risk
- URL: https://www.fdaweb.com/fda-looking-at-ukoniq-death-risk/
- Published: 2022-02-03T12:00:00.000Z
- Updated: 2026-09-14T17:31:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151072

FDA says it is investigating a possible increased risk of death with TG Therapeutics’ Ukoniq (umbralisib), approved to treat two specific lymphomas. An agency [drug safety communication](https://www.fda.gov/drugs/development-approval-process-drugs/fda-investigating-possible-increased-risk-death-lymphoma-medicine-ukoniq-umbralisib?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA has determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the drug.

“Because of the seriousness of this concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial,” the notice says, “we are alerting patients and healthcare professionals that we are reevaluating this risk against the benefits of Ukoniq for its approved uses.”

The agency says it is continuing to evaluate the results from the UNITY trial and has suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while the findings are reviewed.