TG Therapeutics is removing Ukoniq® (umbralisib) from the U.S. market due to a potential increase in the risk of patient death.

• In 2021, the U.S. FDA granted accelerated approval for Ukoniq to treat marginal zone lymphoma and follicular lymphoma. Continued approval was contingent on the results of confirmatory trials.
• The FDA announced in February 2022 that it was investigating a possible increased risk of death in patients treated with Ukoniq. The agency advised healthcare professionals and patients to talk about the potential risks and benefits of the medication versus other available treatments.
• As of June 2022, the FDA concluded that the risks of treatment with Ukoniq outweigh the potential benefits. TG Therapeutics chose to voluntarily withdraw the drug from the market following this determination.