Nordic Nanovector’s Betalutin® Receives Promising Innovative Medicine (PIM) Designation in the UK for the Treatment of Follicular Lymphoma
Oslo, Norway, 25 October 2018
Nordic Nanovector ASA (OSE: NANO) today announces that Betalutin® (177Lu-satetraxetan-lilotomab) has been granted a Promising Innovative Medicine (PIM) designation by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of patients with advanced relapsed/refractory follicular lymphoma (R/R FL). The designation was granted based on data from the first part of the Phase 1/2 LYMRIT 37-01 trial.
Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: “We are delighted by the MHRA’s decision to award PIM designation to Betalutin®. This acknowledges the high unmet medical need of this patient population as well as the potential of Betalutin® to offer therapeutic benefits to FL patients. Both the PIM and Fast Track designations (granted by the FDA in June) are very encouraging, as they provide opportunities for enhanced dialogue with health authorities and the potential to bring Betalutin® to patients more quickly.”
PIM designation constitutes Step 1 of the UK Early Access to Medicines Scheme (EAMS). EAMS aims to give patients in the UK early access to medicines that do not yet have a marketing authorisation but meet a medical need that is currently not being met. PIM designation means that a medicinal product is a promising candidate for the EAMS, for the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.
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Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going.
Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).
Betalutin® has been granted Fast Track designation (in June 2018) in the US for the treatment of patients with R/R FL. Betalutin® also received Orphan Drug designations for FL in both the USA and Europe in 2014.
Betalutin® is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin's lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is internalised, causing DNA damage and cell death.
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 can be found at www.nordicnanovector.com