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The FDA grants TG-1101 and TGR-1202 combination Orphan Drug Designation for DLBCL

Jan 24, 2017

On 24 thJanuary 2017, the U.S. Food and Drug Administration(FDA) granted Orphan Drug Designation covering the combination of TG-1101 (ublituximab)and TGR-1202 for treating DLBCL patients.

TG Therapeutics’TG-1101 is a novel, chimeric Monoclonal Antibody (mAb) specific for a unique epitope of the CD20 antigen and glycoengineered to increase affinity for all FCγRIIIa receptors. This results in more efficient Antibody-Dependent Cellular Cytotoxicity (ADCC) activity compared to ofatumumab and rituximab in vitro, especially directed against cells with low surface expression of CD20. TGR-1202(previously referred to as RP5264) is also owned by TG Therapeutics, and is a next generation, oral PI3Kδ inhibitor.

Currently, this combination is being explored in the phase 2b UNITY-DLBCL trial ( NCT02793583), which is aiming to assess the efficacy and safety of TG-1101 plus TGR-1202 compared to TGR-1202 alone in patients with treatment naïve DLBCL.

The combination TG-1101 - TGR-1202 is also being investigated in patients with treatment naïve or R/R CLL in the phase 3 UNITY-CLL trial ( NCT02612311). The combination was awarded orphan drug designation for CLL by the FDA on 9 thJanuary 2017, as previously reportedby the Lymphoma Hub.

  1. GlobeNewswire. TG Therapeutics Announces Orphan Drug Designation for the Combination of TG-1101 and TGR-1202 for the Treatment of Diffuse Large B-cell Lymphoma. 2017 Jan 24. https://globenewswire.com/news-release/2017/01/24/910328/0/en/TG-Therapeutics-Announces-Orphan-Drug-Designation-for-the-Combination-of-TG-1101-and-TGR-1202-for-the-Treatment-of-Diffuse-Large-B-cell-Lymphoma.html. [Accessed 2017 Jan 24].