TG Therapeutics' Ublituximab Obtains Orphan Drug Designation From FDA

(RTTNews) - TG Therapeutics Inc. (TGTX) announced Monday that ublituximab or TG-1101, the company's novel, glycoengineered anti-CD20 monoclonal antibody has received two Orphan Drug designations from the U.S. Food and Drug Administration or FDA for the treatment of Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma (Mucosa-Associated Lymphatic Tissue, MALT), both rare subtypes of non-Hodgkin's lymphoma or NHL for which there are limited effective treatments.

Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.

Marginal Zone Lymphomas are relatively rare subtype of non-Hodgkin's lymphoma , accounting for approximately 5-10% of all NHLs according to the American Cancer Society. The median age of diagnosis of this type of lymphoma is approximately 66. There are three types of Marginal Zone Lymphoma: extranodal or mucosa associated lymphoid tissue or MALT, occurring outside the lymph nodes; nodal, occurring within the lymph nodes; and splenic, occurring mostly in the spleen and blood. Presently there are no agents approved specifically for the treatment of MZL.