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.
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 has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while it is continuing to review the UNITY findings.
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 they may have, including about possible alternative treatments.
Ukoniq is a prescription medicine approved in February 2021 to treat adults with marginal zone lymphoma ( MZL ) when the disease has returned or it did not respond to prior treatment with at least one specific type of medicine.
Ukoniq is also approved to treat adults with follicular lymphoma ( FL ) when the disease has returned or it did not respond to at least three prior treatments.
Both marginal zone lymphoma and follicular lymphoma are slow-growing cancers that start in lymphocytes, which are part of the body’s immune system.
Ukoniq, which is in a class of medicines called PI3 kinase inhibitors, works by blocking the action of an abnormal protein that signals cancer cells to multiply, which helps stop their spread.
The medicine is available as a tablet to take by mouth.
FDA has 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 that targets a specific protein called CD20 compared to the control arm in which patients received standard treatment.
The results have shown 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 have also experienced more serious adverse events than those in the control arm.
The UNITY trial was conducted in patients with chronic lymphocytic leukemia, which is not an approved use but rather a use of this drug that is being studied; however, these findings have implications for 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. ( Xagena )
Source: FDA, 2022