Home Alzheimer’s Disease FDA Grants Orphan Drug Designation to Umbralisib for Patients with Follicular Lymphoma

FDA Grants Orphan Drug Designation to Umbralisib for Patients with Follicular Lymphoma

The FDA granted orphan drug designation to umbralisib, an investigational dual inhibitor of PI3K-delta and CK1-epsilon, for the treatment of patients with follicular lymphoma, according to TG Therapeutics, the agent’s developer.1

Umbralisib is being evaluated across multiple types of lymphoma in the UNITY-NHL phase IIb registration directed clinical trial, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma. Patients are being randomized to either umbralisib alone, umbralisib plus ublituximab, or umbralisib plus ublituxiumab and bendamustine (Treanda).

The follicular lymphoma cohort within the UNITY-NHL trial is designed to assess the safety and efficacy of umbralisib in patients with follicular lymphoma who have received at least 2 prior lines of therapy, including an anti-CD20 monoclonal antibody and an alkylating…

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