The FDA has just announced that they are reevaluating their approvals for Ukoniq. This reevaluation comes after study findings which demonstrated there may be an increased risk of fatality for patients taking this drug.

UNITY-CLL

The study (UNITY-CLL) where this concern originated was evaluating the combination of an anti-CD20 monoclonal antibody in combination with Ukoniq as a therapeutic option for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL).

This study found that the group of patients in the control group had a lower risk of death than those taking the treatment combination. Additionally, those in the treatment group had more severe adverse events.

Overall survival hazard ratios ultimately determined the hold. The hazard ratio was 1.04. Typically, a cause of concern is a 1 or higher. Drugs which have a ratio lower than 1 improve survival.

What Next?

The FDA will carefully evaluate this treatment to determine if it is safe for use in patients in CLL and non-Hodgkin’s lymphoma. Additionally, they will reevaluate the conditions where Ukoniq is already approved.

For instance, in February 2021 the FDA had approved the treatment for relapsed/refractory marginal zone lymphoma patients who had been treated with an anti-CD20 therapy, as well as relapsed/refractory follicular lymphoma patients who had already tried a minimum of 3 different treatments.

Finally, the FDA has suspended trial enrollment for all Ukoniq trials which are ongoing. This decision will be reevaluated after the full FDA review of the survival concern has been addressed.

You can read more about this suspension and what the process will be for evaluating the treatment’s safety here.