Drug News

FDA Withdraws UKONIQ (umbralisib) Approval Over Safety Concerns

The FDA withdrew approval for a cancer medication known as umbralisib, used to treat marginal zone lymphoma and follicular lymphoma, over safety concerns June 1. Umbralisib (TGR-1202) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. Inhibition of PI3K delta signaling with umbralisib has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies. Umbralisib is currently in Phase 3 clinical development in combination with Ublituximab for patients with hematologic malignancies.

However, 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.

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