FDA Alert: FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns

June 1, 2022 — Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).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).

FDA Alert: FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns
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FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns

June 1, 2022  

June 1, 2022 — Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).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.

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.

https://www.drugs.com/fda/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns-14538.html?