FDA grants priority review to umbralisib for MZL and standard review for FL

On August 12, 2020, the U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for umbralisib, as a treatment option for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).

Umbralisib, an oral dual inhibitor of the PI3 kinase-delta and casein kinase-1 epsilon, has already received FDA breakthrough therapy designation for the treatment of patients with MZL who had received one prior anti-CD20 regimen, and orphan drug designation for patients with FL who were relapsed or refractory following ≥ 2 prior lines of therapy, including an anti-CD20 regimen and an alkylating agent.

The NDA application was based on data from the MZL and FL cohorts of the UNITY-NHL phase IIb trial (NCT02793583). This global multicenter, open-label trial evaluated safety and efficacy of the single agent umbralisib in patients with MZL who had received at least one prior anti-CD20 regimen, and in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. The trial met its primary endpoint of overall response rate, meeting the prespecified targets of 40─50% in both cohorts.

The FDA granted priority review to umbralisib for the MZL indication and standard review for the FL indication.