Monday, June 29, 2020
Nordic Nanovector ASA announces that the US Food and Drug Administration (FDA) has granted Fast Track designation for investigating Betalutin® (177Lu lilotomab satetraxetan) 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 very promising clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01 trial.
Lars Nieba, Interim Chief Executive Officer, commented: "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."
The FDA Fast Track Designation is one of several approaches utilized by the US FDA to expedite development and review of potential medicines for serious conditions and that fulfil unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA review team throughout the development program. Additionally, products that have been granted Fast Track Designation may be eligible for rolling review and priority review, if supported by clinical data.
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.