Ukoniq FDA Warning Issued Over Increased Risk of Death with Cancer Drug

The U.S. Food and Drug Administration (FDA) has issued a warning about an increased risk of death with Ukoniq, a cancer drug used to treat lymphoma, following a preliminary review of a clinical trial that suspended enrollment of new patients amid safety concerns.

The  FDA issued a Ukoniq warning on February 3, indicating that the agency is reevaluating the potential Ukoniq side effects and whether the risks may exceed the benefits provided by the treatment. A public hearing also may be scheduled to discuss whether there should be a Ukoniq recall in the future.

Ukoniq (umbralisib) was only approved a year ago, in February 2021, for the treatment of marginal zone lymphoma (MZL) and recurring follicular lymphoma (FL), which has not responded to at least three previous treatments. Manufactured by TG Therapeutics, Inc., Ukoniq belongs to a class of drugs known as PI3 kinase inhibitors, which block an abnormal protein which causes cancer cells to multiply.

The FDA warning comes as the result of initial review data from a phase 3 randomized, controlled clinical trial involving patients being treated for chronic lymphocytic leukemia (CLL). The preliminary data shows a possible increased risk of death in patients receiving a combination of Ukoniq and a monoclonal antibody. Patients receiving Ukoniq also seem to be experiencing more adverse events, the FDA warns.

“The UNITY trial was conducted in CLL patients, which is not an approved use but rather a use of this drug that is being studied; however, we believe these findings have implications for its approved use for MZL and FL,” the FDA drug safety communication states. “In addition, clinical trials of other medicines in the same PI3 kinase inhibitor class as Ukoniq have shown similar safety concerns.”

In 2015, the FDA issued similar warnings about the cancer drug Zydelig.

For Ukoniq, the FDA is advising health care professionals to review patients’ progress on the drug and discuss the risks and benefits of continuing Ukoniq, as well as discussing other possible treatments. Patients are being advise to talk to their health care professionals about the risks and benefits of Ukoniq and any concerns they may have.

“We are continuing to evaluate the results from the clinical trial called UNITY. FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq,” the agency states. “We have also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while we continue to review the UNITY findings.”

The agency indicates it will communicate its final conclusions and recommendations when the FDA has completed its review or when more data becomes available.

In the meantime, the FDA urges patients and doctors who experience adverse events or complications involving the use of Ukoniq to report them to the FDA’s MedWatch adverse event reporting program.