Withdrawal of Ukoniq (umbralisib) - CLL America Support

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Withdrawal of Ukoniq (umbralisib)

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This came up in my drug recall emails I was wondering if anyone else has heard about it. This is what concerns me about starting a medicine like Zanubrutinib for CLL which is still basically in trials.

"FDA Approval of Lymphoma Medicine Ukoniq (umbralisib) is Withdrawn Due to Safety Concerns

June 1, 2022

Audience: Oncology, Patient, Health Professional, Pharmacy  

June 1, 2022 -- Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).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

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