Other safety alerts
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| The United States: Ukoniq (umbralisib): Drug Safety Communication: FDA investigating possible increased risk of death with lymphoma |
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The US Food and Drug Administration (FDA) announces that it 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. FDA 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, FDA is alerting patients and health care professionals that it is re-evaluating this risk against the benefits of Ukoniq for its approved uses.
FDA is 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. FDA has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while FDA continues to review the UNITY findings. FDA will communicate its final conclusions and recommendations when it has completed its review or has 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 their health care professionals about the risks and benefits of Ukoniq or any concerns they may have, including about possible alternative treatments.
FDA conducted an initial review of data from UNITY, a phase 3, randomized, controlled clinical trial in patients with chronic lymphocytic leukemia (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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/development-approval-process-drugs/fda-investigating-possible-increased-risk-death-lymphoma-medicine-ukoniq-umbralisib
In Hong Kong, there is no registered pharmaceutical product containing umbralisib.
Ends/Friday, Feb 4, 2022
Issued at HKT 16:00
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