FDA investigate possible increased risk of death with lymphoma medicine

pharmafile | February 9, 2022 | News story | Research and Development  

The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib). The administration is continuing to evaluate results from the UNITY clinical trial, determining that “initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible increased risk of death in patients taking the medicine.”

Ukoniq is approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. The drug is approved for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one previous anti-CD20-based treatment and for adults with relapsed or refractory follicular lymphoma (FL) who have received at least three previous lines of systemic therapy.

“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, we are alerting patients and health care professionals that we are re-evaluating this risk against the benefits of Ukoniq for its approved uses,” the FDA shared.

Ukoniq is an oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta plays a role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity. CK1-epsilon regulates oncoprotein translation.

“We urge health care professionals and patients to report side effects involving Ukoniq or other medicines to the FDA MedWatch program,” the agency shared, and advised that “Patients should talk to your health care professionals about the risks and benefits of Ukoniq or any concerns you may have, including about possible alternative treatments.” The FDA also urged healthcare professionals to “review patients’ progress on Ukoniq, and discuss with them the risks and benefits of continuing Ukoniq in the context of other available treatments.”

Ana Ovey

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