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Nordic Nanovector' Betalutin Gets Fast-track Designation From FDA For Marginal Zone Lymphoma

Nordic Nanovector ASA (NVO) said Monday that the U.S. Food and Drug Administration has granted Fast Track designation for investigating Betalutin for the treatment of adult patients with relapsed or refractory marginal zone lymphoma or MZL who have received at least two prior systemic therapies.

The company said it is evaluating the opportunity to develop Betalutin as a single-agent treatment for MZL, a rare type of non-Hodgkin's lymphoma or NHL.

Betalutin has demonstrated a very promising clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01 trial

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.

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.

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