USA – FDA withdraws cancer drug approval after finding possible higher death rates

The US Food and Drug Administration has rescinded its approval of TG Therapeutics’ Ukoniq (umbralisib) after a clinical trial found patients on the cancer drug may have a higher mortality rate. The news comes a month and a half after the company voluntarily pulled the drug from market for the same reason.

On 1 June, the FDA issued a safety communication that it was withdrawing approval of Ukoniq which had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL). After reviewing data from the UNITY phase III clinical trial which was evaluating the drug’s safety and efficacy as a treatment for chronic lymphocytic leukemia (CLL), the agency said it found patients on the drug had a higher mortality rate.

“The results showed a possible increased risk of death in patients receiving the combination of Ukoniq and the monoclonal antibody compared to the control arm,” the FDA said. “Those receiving the combination of Ukoniq and the monoclonal antibody also experienced more serious adverse events than those in the control arm.”…