Nordic Nanovector’s Betalutin® Receives Positive Opinion for Orphan Drug Designation from EMA for Marginal Zone Lymphoma (MZL)
Oslo, Norway, 14 May 2020 Nordic Nanovector ASA (OSE: NANO) today announces that Betalutin® ([177]Lu lilotomab satetraxetan) has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan drug designation for the treatment of marginal zone lymphoma (MZL). The positive opinion is expected to be adopted by the European Commission shortly. In the LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any