The FDA withdrew approval for umbralisib, a medication used to treat marginal zone lymphoma and follicular lymphoma, over safety concerns June 1.
Updated findings from the clinical trial of the medication, which goes by the brand name Ukoniq, continued to show a possible increased risk of death. The agency determined the risks of the medication outweigh its benefits.
The FDA issued an accelerated approval of the drug Feb. 15, 2021. The manufacturer, TG Therapeutics, issued a voluntary recall of the drug April 15.
Healthcare providers should stop prescribing the medication to patients and seek alternative treatments, and patients should be informed of the risks and advised to cease taking the medication, according to the FDA.
"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 said.