June 2022 FDA Drug Safety Communication Makes Clear That Ukoniq Was Removed From Market Due to Safety Issues
(Posted by Tom Lamb at Drug Injury Watch)
On June 1, 2022, the FDA issued an update to the "FDA Drug Safety Communication: FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)" which it issued back in February 2022, making clear that the Ukoniq drug recall is due to safety issues.
In this June 2022 document, "Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns", we get an explanation of how the possible increased risk of death associated with Ukoniq outweighs the benefits of Ukoniq:
Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, we determined the risks of treatment with Ukoniq outweigh its benefits. Based upon this determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market for the approved uses in MZL and FL.
Health care professionals should stop prescribing Ukoniq and switch patients to alternative treatments. Inform patients currently taking Ukoniq of the increased risk of death seen in the clinical trial and advise them to stop taking the medicine. In limited circumstances in which a patient may be receiving benefit from Ukoniq, TG Therapeutics plans to make it available under expanded access.
Patients should talk to your health care professionals about alternative treatments and stop taking Ukoniq....
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This recent FDA action formalizes an April 15, 2022 announcement by TG Therapeutics Inc. that it is pulling Ukoniq from the market after a study showed a possible increased risk of death in patients using Ukoniq.
A June 1, 2022, Fierce Pharma article, "After flagging death risks, FDA rescinds accelerated approval for TG Therapeutics' Ukoniq", provides some additional contextual information.
Approved in February of 2021, TG Therapeutics’ first-in-class drug Ukoniq was billed as a potentially safer treatment for lymphoma patients.
But 16 months later, the FDA has rescinded its approval of Ukoniq because of concerns that its use might increase the risk of death. The risk, along with other adverse side effects, became apparent during a phase 3 trial of the drug in combination with TG's ublituximab in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) patients....
Ukoniq is a member of the PI3K-delta inhibitor class. Others in the class that are on the market—including Gilead’s Zydelig and Verastem’s Copiktra—carry black box warnings for side effects. When Ukoniq gained its green light, its label included warnings, but not in a black box.
For more background, here are three earlier Drug Injury Watch articles about Ukoniq:
- Ukoniq Drug Recall in April 2022 Comes Soon After FDA Warning About Increased Risk of Death in February 2022 (April 18, 2022)
- Ukoniq FDA Advisory Committee Meeting in April 2022 Will Evaluate Ukoniq Drug Safety Findings (March 15, 2022)
- Ukoniq Lymphoma Drug Safety Investigation Started In February 2022 to Examine Increased Risk of Death (February 4, 2022)
In connection with this recent Ukoniq drug recall for safety reasons, we are investigating possible Ukoniq drug injury lawsuits against TG Therapeutics for cases involving patient deaths or serious side effects that may have been caused by Ukoniq.
We encourage you to submit a Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ukoniq drug injury case.
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