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(177)Lu lilotomab satetraxetan receives positive opinion for orphan drug designation from EMA for MZL

May 20, 2020

On May 14, 2020, 177Lu lilotomab satetraxetan received a positive opinion from the European Medicines Agency for an orphan drug designation application for the treatment of marginal zone lymphoma (MZL). The adoption of the positive opinion by the European Commission is expected to occur shortly. 1

177Lu lilotomab satetraxetan is a next generation β-particle emitting radioimmunoconjugate that sensitizes and upregulates CD37+ B-cell cancer cells before treatment with CD20 immunotherapy. Particularly, it has been shown to act synergistically with rituximab. 2

The positive opinion was based on positive data from the LYMRIT-37-01 phase I/IIa ( NCT01796171) trial in patients with relapsed indolent non-Hodgkin lymphoma. In the MZL patient arm (n = 9; heavily pretreated patients with advanced disease), the overall response rate was 78%, and 44% of patients achieved a complete response. Data from this trial were encouraging as a once-only administration of 177Lu lilotomab satetraxetan resulted in the highest response rate of any patient subpopulation in this trial. 1

177Lu lilotomab satetraxetan has previously been granted fast-track designation in the US for the treatment of patients with relapsed or refractory follicular lymphoma after ≥ 2 prior systemic therapies. 3

  1. PR Newswire. Nordic Nanovector's Betalutin® receives positive opinion for orphan drug designation from EMA for marginal zone lymphoma (MZL). https://www.prnewswire.co.uk/news-releases/nordic-nanovector-s-betalutin-r-receives-positive-opinion-for-orphan-drug-designation-from-ema-for-marginal-zone-lymphoma-mzl--823693112.html. Published May 14, 2020. Accessed May 18, 2020.
  2. Malenge MM, Patzke S, Ree AH,  et al. 177Lu-lilotomab satetraxetan has the potential to counteract resistance to rituximab in non-Hodgkin’s lymphoma. J Nucl Med. 2020. DOI: 10.2967/jnumed.119.237230
  3. PR Newswire. Nordic Nanovector announces Betalutin® has been granted fast track designation in the US for follicular lymphoma. https://www.prnewswire.com/news-releases/nordic-nanovector-announces-betalutin-has-been-granted-fast-track-designation-in-the-us-for-follicular-lymphoma-300664612.html. Published Jun 12, 2018. Accessed May 18, 2020.