Nordic Nanovector’s Betalutin® Receives Positive Opinion for Orphan Drug Designation from EMA for Marginal Zone Lymphoma (MZL)

On May 14, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Betalutin (177Lu 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) (Press release, Nordic Nanovector, MAY 14, 2020, View Source [SID1234558090]). The positive opinion is expected to be adopted by the European Commission shortly.

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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 patient sub-population in this study. This followed a once-only administration of Betalutin in this heavily pre-treated group of patients with advanced disease.

MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL) that accounts for approximately eight percent of all NHL cases. EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare (affecting not more than five in 10,000 people in the European Union). Medicines that meet the EMA’s orphan designation criteria qualify for several incentives to help support advancement.

Betalutin received Orphan Drug Designation for the treatment of follicular lymphoma in the US and Europe in 2014.

Lars Nieba, Interim Chief Executive Officer, commented "We are very pleased to receive a positive opinion on Orphan Drug Designation in the European Union for Betalutin in MZL. There is a clear need for new therapeutic options for MZL patients who no longer respond to anti-CD20 immunotherapy (rituximab), the current backbone of treatment in first and second-line patients. We look forward to receiving the final decision by the European Commission in the coming weeks."