Ukoniq Side Effects Linked to Increased Risk of Death, FDA Warns, Withdraws Drug Approval

The risk of death from Ukoniq side effects results in the drug being removed from the market less than two years after receiving FDA approval.

Federal regulators have withdrawn approval for the lymphoma drug Ukoniq, after less than two years on the market, indicating that the increased risk of death associated with the drug outweighs any health benefits.

Ukoniq (umbralisib) is a TG Therapeutics drug approved by the FDA in February 2021, for the treatment of marginal zone lymphoma and follicular lymphoma. Ukoniq belongs to a class of drugs known as PI3 kinase inhibitors, which block an abnormal protein which causes cancer cells to multiply. It was allowed on the market through the FDA’s Accelerated Approval program.

The FDA issued an Ukoniq drug safety communication, announcing it is rescinding approval of the drug, after discovering that patients were dying at a high rate.

The decision came after the review of data from a clinical trial that was intended to determine whether use of the drug could be expanded for treatment of chronic lymphocytic leukemia (CLL), when combined with the investigational monoclonal antibody drug, ublituximab. However, TG Therapeutics issued a Ukoniq recall to remove the drug from the market last month, clearly in anticipation of this FDA decision that the risks out weigh the potential benefits.

The FDA began investigating the potential Ukoniq side effects in February, and suspended enrollment in the CLL clinical trial, known as UNITY-CLL. It issued an Ukoniq warning on February 3.

Preliminary data has shown a possible increased risk of death in patients receiving a combination of Ukoniq and the monoclonal antibody. Patients receiving Ukoniq also seemed to be experiencing more adverse events, the FDA warned. As a result, the FDA recommends health care professionals stop prescribing Ukoniq and switch patients to an alternative treatment.

“Inform patients currently taking Ukoniq of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine,” the FDA safety communication advises. “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 advises patients to talk to their health care professionals about alternative treatments to Ukoniq and recommends disposing of the drug by taking it to a drug take-back location, such as a pharmacy. However, if no such location is available, the medicine can be disposed of in household trash if it s mixed with an unappealing substance like dirt, cat litter, or coffee grounds, placed in a sealed bag and thrown away in a home trash container. Patients should delete personal information from the prescription labels of the empty medicine bottles and then recycle or discard them.

The FDA is urging health care professionals and patients to report any adverse events linked to Ukoniq use to the agency’s MedWatch adverse event reporting program.