FDA grants priority review to umbralisib for marginal zone lymphoma
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The FDA granted priority review to umbralisib for patients with previously treated marginal zone lymphoma, according to the agent’s manufacturer.
The designation applies to use of the agent by patients who received at least one prior anti-CD20-based regimen.
Umbralisib (TGR1202, TG Therapeutics) is an oral dual inhibitor of the PI3 kinase-delta and casein kinase-1 epsilon.
The FDA previously granted breakthrough therapy designation to the agent for marginal zone lymphoma.
A decision on approval for this indication is expected by Feb. 15.
The agency also is reviewing umbralisib as a potential treatment for patients with follicular lymphoma who received at least two prior systemic therapies. A decision on that indication is expected by June 15.
“We are extremely pleased with the FDA’s acceptance of our first new drug application submission and look forward to working with the FDA during the review process,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in a company-issued press release. “This is a significant achievement in our path toward accomplishing our goal of developing novel treatments for patients with B-cell diseases.”
The phase 2b UNITY-NHL trial evaluated umbralisib monotherapy for patients with relapsed or refractory marginal zone lymphoma or follicular lymphoma. The study met its primary endpoints, with overall response rates in each cohort meeting the prespecified targets of 40% to 50%. Full data from the study will be presented by the end of this year, Weiss said.
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