Umbralisib (Ukoniq) is a kinase inhibitor currently approved to treat two types of lymphoma: relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. As a kinase inhibitor, umbralisib blocks the action of an abnormal protein that provides signals to cancer cells to multiply. Blocking this protein inhibits the cancer cells from developing new cells.
Umbralisib has also been studied in a phase 3 randomized controlled clinical trial to see if it's effective against chronic lymphocytic leukemia when given concurrently with a monoclonal antibody that targets a specific protein called CD20. In an initial review of the trial's findings, there was a possible increased risk of death in those patients receiving umbralisib. These patients were also more likely than those receiving placebo to experience serious adverse effects.
The Food and Drug Administration (FDA) will continue to evaluate the results of the clinical trial and has suspended enrollment of new patients in other trials of umbralisib. The FDA will reevaluate the risks versus the benefits of umbralisib for currently approved indications based on these new data and will communicate its final decision concerning risk at that time.
The FDA is encouraging health care providers to evaluate their patients' progress if patients were prescribed umbralisib for one of the approved indications. Patients should be made aware of the drug's potential risks. Currently, umbralisib's labeling contains warnings about the following adverse effects: infections, neutropenia, diarrhea or noninfectious colitis, hepatoxicity, severe cutaneous reactions, allergic reactions due to the inactive ingredient FD&C Yellow No. 5, and embryo-fetal toxicities. Nurses and other health care providers who note adverse effects from umbralisib should report them to the FDA's MedWatch program at http://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
To read the FDA Drug Safety Communication regarding umbralisib, go to http://www.fda.gov/drugs/development-approval-process-drugs/fda-investigating-po.