FDA Approves Ukoniq in Certain Previously Treated Patients with Marginal Zone and Follicular Lymphoma

The Food and Drug Administration (FDA) on Friday granted Ukoniq (umbralisib) an accelerated approval for the treatment of certain adults with relapsed or refractory marginal zone lymphoma (MZL) and relapsed or refractory follicular lymphoma (FL), according to the agent’s manufacturer, TG Therapeutics.

The agency’s decision was based on overall response rate data from two single-arm cohorts of an open-label, multicenter trial. In the phase 2 UNITY-NHL trial, 69 patients with MZL who had previously received at least one therapy, including an anti-CD20 containing regimen, and 117 patients with follicular lymphoma who had previously received at least two systemic therapies received a once-daily dose of Ukoniq until their disease progressed or the drug became too toxic.

“Despite treatment advances, (marginal zone lymphoma) and (follicular lymphoma) remain incurable diseases with limited treatment options for patients who relapse after prior therapy and no defined standard of care,” study chair Dr. Nathan Fowler, a professor of medicine at The University of Texas MD Anderson Cancer Center, said in the press release. “With the approval of (Ukoniq) we now have a targeted, oral, once-daily option, offering a needed treatment alternative for patients.”

The data demonstrated that the drug induced on overall response rate of 49% in patients with MZL, with 16% achieving a complete response. Patients in the MZL treatment arm had not yet reached a median duration of response.

Treatment with Ukoniq correlated to an overall response rate of 43% in the follicular lymphoma arm, of which 3% achieved a complete response. That treatment arm reached a median duration of response of 11.5 months.

“The approval of (Ukoniq) for the treatment of relapsed/refractory marginal zone lymphoma and follicular lymphoma offers patients a new treatment option, and new hope in the fight against these diseases,” Lymphoma Research Foundation CEO Meghan Gutierrez said in the release.

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