FDA Withdraws Approval of Lymphoma Rx

FDA withdraws approval of lymphoma medicine Ukoniq (umbralisib)

(RxWiki News) The US Food and Drug Administration (FDA) has withdrawn its approval of a lymphoma medication due to safety concerns.

The agency announced that it was withdrawing its approval of Ukoniq (umbralisib) due to a possible increased risk of death associated with its use.

In early 2021, this medication received accelerated approval to treat relapsed or refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) in patients who had not seen improvement with prior therapies.

According to the FDA, an ongoing trial of the drug began to show signs that there could be an increased risk of death. Further study appeared to confirm that theory.

"As a result, we determined the risks of treatment with Ukoniq outweigh its benefits," the agency wrote on its website. "Based upon this determination, the drug’s manufacturer, TG Therapeutics, announced it was voluntarily withdrawing Ukoniq from the market ..."

The FDA advised health care providers to stop prescribing this medication and opt for alternatives. It also advised those taking the drug to reach out to their health care providers to discuss alternative treatments and stop taking the drug.

If you are currently taking Ukoniq, reach out to your health care provider immediately.

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Review Date: 
June 15, 2022