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Kiromic BioPharma, Inc. (OTCQB:KRBP) ("Kiromic" or the "Company") announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least two lines of standard of care therapy including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapy to improve progression-free survival and overall survival. Deltacel is currently being evaluated in the Deltacel-01 Phase 1 study in patients with stage 4 NSCLC who have failed to respond to standard therapies.
Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The designation allows for more frequent communication with the FDA, potential priority review, and a rolling submission of Biologics License Application or New Drug Application.
Posted In: KRBP
