Posted by Michael Wonder on 13 Jun 2018
Nordic Nanovector announces Betalutin has been granted fast track designation in the US for follicular lymphoma
12 June 2018 - Nordic Nanovector announces that the US FDA has granted fast track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma after at least 2 prior systemic therapies.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are pleased to have been granted fast track designation for Betalutin. 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. We are now focusing the PARADIGME trial on 3L CD20-refractory follicular lymphoma (FL) patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin”.
PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin dosing regimens (15 MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100 mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.
