FDA grants orphan drug designation to TG Therapeutics to treat Diffuse Large B-cell Lymphoma

Release Date: 02-Feb-2017

US Food and Drug Administration (FDA) has granted orphan drug designation to covering the combination of TG-1101 (ublituximab), the TG Therapeutics' s novel, glycol-engineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).

The combination of TG-1101 and TGR-1202 is currently being examined in the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory DLBCL as well as the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated chronic lymphocytic leukemia (CLL). Diffuse Large B-Cell Lymphoma is an aggressive type of non-Hodgkin lymphoma (NHL), a cancer starting in cells called lymphocytes, which are part of the body’s immune system.

FDA's Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status. Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.

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