Hyped as a safer version of other drugs in its class upon its approval last February, TG Therapeutics’ Ukoniq appeared on its way to differentiating itself in certain types of lymphoma.
But a year later, Ukoniq is under scrutiny as the FDA is investigating whether it increases the risk of death. The concerns stem from findings in a phase 3 trial testing the drug in combination with TG Therapeutics’ monoclonal antibody ublituximab in people with chronic lymphocytic leukemia (CLL).
Ukoniq is marketed to treat two other types of lymphoma—relapsed or refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL). An approval to treat CLL, which is much more prevalent, would be a major coup for TG as Ukoniq is its only FDA-sanctioned drug.
