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Leo I. Gordon, MD, FACP

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FDA Withdraws Approval of Umbralisib for Treatment of Lymphomas Over Safety Concerns

By: JNCCN 360 Staff
Posted: Monday, June 6, 2022

On June 1, the U.S. Food and Drug Administration (FDA) announced it has withdrawn its approval of umbralisib (Ukoniq). The oral inhibitor of PI3K-delta and CK1-epsilon was approved to treat both marginal zone and follicular lymphomas.

The decision was based on updated findings from the UNITY-CLL trial, which continued to show a possible increased risk of death in patients receiving umbralisib. Consequently, the FDA determined that the risks of treatment with umbralisib outweigh its benefits. Based on this decision, the manufacturer of umbralisib, TG Therapeutics, announced it was voluntarily withdrawing it from the market for the approved uses in these two types of lymphoma.

From the FDA statement: “Health-care professionals should stop prescribing [umbralisib] and switch patients to alternative treatments. Inform patients currently taking [umbralisib] 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 [umbralisib], TG Therapeutics plans to make it available under expanded access.”


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