Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).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, FDA 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.
References:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-approval-lymphoma-medicine-ukoniq-umbralisib-withdrawn-due-safety-concerns
https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-voluntary-withdrawal-blasnda-u2-treat
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