TG Therapeutics, Inc.
TGTX, an innovative, clinical-stage biopharmaceutical company focused
on the acquisition, development and commercialization of medically important
pharmaceutical products for the treatment of cancer and other underserved
therapeutic needs, today announced that ublituximab (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 (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 (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. The designation provides the drug
developer with a seven-year period of U.S. marketing exclusivity if the drug
is the first of its type approved for the specified indication or if it
demonstrates superior safety, efficacy, or a major contribution to patient
care versus another drug of its type previously granted the designation for
the same indication, as well as with tax credits for clinical research costs,
the ability to apply for annual grant funding, clinical research trial design
assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
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