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June 14, 2018

FDA fast-tracks Nordic Nanovector’s Betalutin for follicular lymphoma

Norwegian biotechnology firm Nordic Nanovector has secured fast-track status from the US Food and Drug Administration (FDA) for its Betalutin (177Lu-lilotomab satetraxetan) drug to treat follicular lymphoma (FL).

Norwegian biotechnology firm Nordic Nanovector has secured fast-track status from the US Food and Drug Administration (FDA) for its Betalutin (177Lu-lilotomab satetraxetan) drug to treat follicular lymphoma (FL).

Betalutin is an anti-CD37 antibody (lilotomab) linked to a low-intensity radionuclide (lutetium-177). It gets internalised in cancer cells and prolonged exposure of the nucleus to radiation kills DNA resulting in the death of the tumour cell.

The drug also has a crossfire effect that destroys surrounding cancer cells, however, it is limited to a radius of 40 cells.

Nordic Nanovector is seeking approval for the use of the drug in relapsed or refractory FL patients who have received at least two previous systemic therapies.

Nordic Nanovector chief medical officer Lisa Rojkjaer said: “This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin to be a new therapeutic option for these patients.

“This designation highlights the potential of Betalutin to be a new therapeutic option for these patients.”

“We are now focusing the PARADIGME trial on third line (3L) CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin.”

In the Phase I/IIa LYMRIT 37-01 trial, Betalutin is reported to have shown positive efficacy and tolerability profile in subjects suffering from relapsed or refractory FL.

The global, randomised Phase IIb PARADIGME trial is designed to evaluate 15MBq/kg and 20MBq/kg Betalutin regimens in around 130 patients at 80-85 clinical sites across approximately 20 countries.

While the primary endpoint for this trial is overall response rate (ORR), its secondary endpoints include duration of response (DoR), overall survival (OS), safety, progression free survival (PFS) and quality of life.

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