Nordic Nanovector has 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.
“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,” says Lisa Rojkjaer, CMO, Nordic Nanovector.
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.
Photo of Lisa Rojkjaer, CMO, Nordic Nanovector