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FDA grants orphan drug designation to TG-1101, TGR-1202 combination for DLBCL
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The FDA granted orphan drug designation to the combination use of TG-1101 and TGR-1202 for the treatment of patients with diffuse large B-cell lymphoma, according to the drugs’ manufacturer.
The phase 2b UNITY-DLBCL trial — designed to evaluate the combination of TG-1101 (ublituximab, TG Therapeutics) and TGR-1202 (TG Therapeutics) in patients with relapsed or refractory diffuse large B-cell lymphoma — is underway.
The FDA previously granted the combination of TG-1101— a glycoengineered anti-CD20 monoclonal antibody — and TGR-1202, a next-generation PI3K delta inhibitor, orphan drug designation for treatment of patients with chronic lymphocytic leukemia. The phase 3 UNITY-CLL trial is evaluating the combination for that patient population.
“We are pleased to receive orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 in diffuse large B-cell lymphoma. This status complements our already strong proprietary protection portfolio,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in a company-issued press release. “DLBCL is an area of significant unmet medical need. ... We are highly encouraged by the early clinical data we have seen in DLBCL patients treated with 1101 plus 1202 and look forward to evaluating this further in our ongoing phase 2b registration-directed trial.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.