OSLO, Norway, June 12, 2018 /PRNewswire/ --
Nordic Nanovector ASA (OSE: NANO) 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.
About Fast Track designation
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
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VP Investor Relations and Corporate Communications
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Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). CD37 is highly expressed in B-cell non-Hodgkin's lymphoma (NHL), representing a novel therapeutic target. Betalutin® is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin® also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells. Betalutin® has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).
About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information about the Company can be found at www.nordicnanovector.com
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SOURCE Nordic Nanovector