Because of safety concerns, the U.S. Food and Drug Administration (FDA) withdrew its approval of umbralisib (Ukoniq®) on June 1, 2022. Umbralisib had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).

FDA Withdraws Approval of Umbralisib Because of Safety Concerns

Updated findings from the UNITY-CLL clinical trial demonstrated a possible increased risk of death in patients receiving umbralisib. As a result, FDA determined that the risks of treatment with umbralisib outweigh its benefits. Based on the determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing umbralisib from use for MZL and FL.

Healthcare professionals should stop prescribing umbralisib, switch patients to alternative treatments, and inform patients currently taking umbralisib of the increased risk of death seen in the clinical trial. Patients should stop taking umbralisib and dispose of any unused product. In limited circumstances in which a patient may be receiving benefit from umbralisib, TG Therapeutics reported availability under expanded access.

Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.