Safety concerns prompt FDA to withdraw Ukoniq approval for two types of lymphoma
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The FDA has withdrawn approval of umbralisib for marginal zone lymphoma and follicular lymphoma due to safety concerns, according to an updated drug safety communication.
Umbralisib (Ukoniq, TG Therapeutics) is a dual inhibitor of the PI3 kinase-delta and CK1-epsilon.
FDA officials determined the risks outweigh the benefits of treatment with umbralisib based on updated results of the randomized phase 3 UNITY-CLL trial, which continued to show a possible increased risk for death among patients who received the agent.
TG Therapeutics announced in April that it voluntarily withdrew umbralisib from the market for the approved lymphoma indications.
Umbralisib received FDA accelerated approval last year for adults with marginal zone lymphoma who received at least one prior anti-CD20-based regimen, as well as adults with follicular lymphoma who received at least three prior lines of systemic therapy. The UNITY trial evaluated umbralisib in combination with a CD20-targeting monoclonal antibody drug as treatment for chronic lymphocytic leukemia.
The FDA urged health care providers to stop prescribing Ukoniq and switch patients to alternative therapies.
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