Nordic Nanovector ASA announces that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) 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 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 (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.
The primary endpoint for the study is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. An initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.