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FDA Grants Orphan Designation to Ublituximab and TGR-1202 for DLBCL

December 30, 2021

The U.S. Food and Drug Administration granted orphan drug designation for ublituximab (an anti-CD20 monoclonal antibody) in combination with TGR-1202 (a next generation phosphoinositide 3-kinase delta inhibitor) to treat diffuse large B-cell lymphoma (DLBCL).

The combination is being studied in the phase IIb UNITY-DLBCL trial that includes patients with relapsed/refractory DLBCL.

Ubiltuximab and TGR-1202 combination was previously grated orphan drug designation for the treatment of chronic lymphocytic leukemia.

Source: FDA news release, January 24, 2017.

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