FDA Investigates Safety of TG Therapeutics’ Lymphoma Drug

The FDA is investigating TG Therapeutics’ Ukoniq (umbralisib) after preliminary phase 3 trial results suggested the cancer drug possibly increased risk of death.

The agency has also suspended enrollment of new patients in other ongoing clinical trials of Ukoniq while it reviews the findings.

Ukoniq was granted accelerated approval last February for treating adults with relapsed or refractory marginal zone lymphoma who have undergone at least one prior anti-CD20-based regimen and adults with relapsed or refractory follicular lymphoma who have been previously treated with at least three lines of therapy.

The FDA said it will convene a meeting of its Oncologic Drugs Advisory Committee to review TG’s submission for Ukoniq plus ublituximab as a treatment for adults with chronic lymphocytic leukemia and small lymphocytic leukemia. The expert panel will consider the preliminary phase 3 trial results.