FDA investigates potential increased death risk with lymphoma therapy Ukoniq
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The FDA is investigating a possible increased mortality risk with umbralisib, approved in the United States for treatment of two types of lymphoma.
Umbralisib (Ukoniq, TG Therapeutics) is a dual inhibitor of the PI3 kinase-delta and CK1-epsilon.
The FDA last year granted accelerated approval of the agent 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.
In a drug safety communication issued today, the agency announced it determined initial findings from the randomized phase 3 UNITY trial — designed to evaluate umbralisib in combination with a CD20-targeting monoclonal antibody drug as treatment for chronic lymphocytic leukemia — showed a possible increased risk for death among patients assigned the experimental combination compared with those who received standard therapy. Results also showed more serious adverse events in the combination group.
Clinical trials of other agents in the same PI3 kinase inhibitor class as umbralisib showed similar safety concerns, according to the FDA.
“Because of the seriousness of this safety concern and the similarities between the two types of cancer for which this drug is approved and the type of cancer that was studied in the clinical trial, the FDA is alerting patients and health care professionals that FDA is re-evaluating this risk against the benefits of Ukoniq for its approved uses,” the agency’s statement read.
The FDA will continue to evaluate the UNITY trial results and may hold a public meeting to discuss the findings and the continued marketing of umbralisib. The agency also suspended enrollment of new patients in other ongoing clinical trials of umbralisib.
“The FDA will communicate our final conclusions and recommendations when the FDA has completed the review or has more information to share,” the safety communication stated.
The FDA urged health care providers to review their patients’ progress on umbralisib and talk with them about the benefits and risks of continued treatment with the agent in the context of other available therapies.
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