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

On 24th January 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 9th January 2017, as previously reported by 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].