Nordic Nanovector has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for investigating Betalutin for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic therapies.
Nordic Nanovector is evaluating the opportunity to develop Betalutin as a single-agent treatment for MZL, a rare type of non-Hodgkin’s lymphoma (NHL). Betalutin has demonstrated a clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01 trial.
“We are very pleased to receive Fast-track designation for Betalutin in MZL, which recognizes the clear need for new therapeutic options for patients with advanced MZL patients who no longer respond to the therapies they have been receiving. We are evaluating the opportunity for investigating Betalutin in this important and underserved indication and will provide an update when we have made a decision,” says Lars Nieba, Interim Chief Executive Officer, Nordic Nanovector.
Betalutin has received Orphan Drug Designation in the European Union for the treatment of MZL and has applied for the equivalent designation in the US.