Nordic Nanovector’s Betalutin® Receives Fast-Track Designation from US FDA for Marginal Zone Lymphoma
Nordic Nanovector ASA (OSE: NANO) today 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.
About Marginal Zone Lymphoma (MZL)
Marginal Zone Lymphoma is an incurable and long-term debilitating disease due to its effects on the spleen, lymph nodes and bone marrow, as well as the increased risk of infection.
Fast Track Designation is granted to drugs and biologics being developed for the treatment of serious or life-threatening diseases and nonclinical or clinical data have demonstrated the potential to address an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions.
In Nordic Nanovector’s 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.
1 Source: Food and Drug Administration, “Expedited Programs for Serious Conditions – Drugs and Biologics”: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
For further information, please contact:
Malene Brondberg, CFO
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
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