Possible Increased Risk for Death with Umbralisib (Ukoniq)
The FDA released a Drug Safety Communication on February 3, 2022 warning of possible increased risk of death with umbralisib (Ukoniq) used for the treatment of lymphoma.1 Umbralisib is a PI3 kinase inhibitor approved by the FDA in February 2021. It is indicated for the treatment of marginal zone lymphoma (MZL) with at lest one prior anti-CD20-based regimen and follicular lymphoma (FL) with at least three prior lines of systemic therapy.
Umbralisib (Ukoniq) is being studied in combination with ublituximab, a monoclonal antibody, for the treatment of CLL. During this phase III study, the FDA noted a possible increased risk of death in patients receiving the combination of umbralisib (Ukoniq) and the ublituximab compared to the control arm. Those receiving the combination of umbralisib (Ukoniq) and the ublituximab also experienced more serious adverse events than those in the control arm. These findings are consistent with clinical trial findings of other medicines in the same PI3 kinase inhibitor class.
The FDA has placed a partial hold on studies of umbralisib (Ukoniq) and the ublituximab2 as they continue to evaluate the results from the Unity trial. The FDA will communicate final conclusions and recommendations once the review is completed.
Recommendations for Patients
- Talk to your health care professionals about the risks and benefits of ublixuximab (Ukoniq) or any other concerns you may have, including about possible alternative treatments.
Recommendations for Health Care Providers
- Review the patients' progress on ublixuximab (Ukoniq) and discuss with them the risks and benefits of continuing therapy in the context of other available treatments.
To help the FDA track safety issues with ublixuximab (Ukoniq) and other medications, please report adverse events to the MedWatch program as recommended in the Indian Health Manual. Instructions for reporting can be found online at the NPTC Pharmacovigilance website
Food and Drug Administration. (2022, February 3). FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
Singh, V. (2022, January 28). TG Therapeutics falls 30% as CEO discloses partial clinical hold on blood cancer trials . News release. TG Therapeutics. Cancer Research.