FDA Investigating Possible Increased Risk of Death with Lymphoma Medicine Ukoniq (umbralisib) The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq (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. 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. | 
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