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  1. FDA Drug Safety Podcasts

FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)

FDA Drug Safety Podcast


Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On February 3, 2022, FDA announced that it is investigating a possible increased risk of death with the cancer medicine Ukoniq (active ingredient umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. We determined 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. 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.

We are continuing to evaluate the results from the clinical trial called UNITY. FDA may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq. We have also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while we continue to review the UNITY findings. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.

Health care professionals should review patients’ progress on Ukoniq and discuss with them the risks and benefits of continuing Ukoniq in the context of other available treatments.

We conducted an initial review of data from UNITY, a phase 3, randomized, controlled clinical trial in patients with chronic lymphocytic leukemia (or CLL). The trial is evaluating Ukoniq in combination with a monoclonal antibody drug that targets a specific protein called CD20 compared to the control arm in which patients received standard treatment. The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm. Those receiving the combination of Ukoniq and the monoclonal antibody also experienced more serious adverse events than those in the control arm. The UNITY trial was conducted in CLL patients, which is not an approved use but rather a use of this drug that is being studied; however, we believe these findings have implications for its approved uses for marginal zone lymphoma and follicular lymphoma. In addition, clinical trials of other medicines in the same PI3 kinase inhibitor class as Ukoniq have shown similar safety concerns.

Side effects involving Ukoniq should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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