BRIEF—Fast Track for Nordic Nanovector cancer candidate

Nordic Nanovector has won Fast Track designation from the US Food & Drug Administration for Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL).

Chief medical officer Lisa Rojkjaer said the designation was “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.”

The company says it will now kick off a new Phase IIb study, PARADIGME, initial efficacy and safety data from which could be available in the first half of 2020.