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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.
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Your opinion matters
Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?