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(177)Lu lilotomab satetraxetan receives Fast Track designation from the FDA for marginal zone lymphoma
On June 29, 2020, the Food and Drug Administration (FDA) granted Fast Track designation to 177Lu lilotomab satetraxetan for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received ≥ 2 prior systemic therapies.1
177Lu lilotomab satetraxetan is a novel β-emitting anti-CD37 antibody–radionuclide conjugate2 in a ready-to-use formulation for single-dose administration. The Fast Track designation was based on the phase I/IIa LYMRIT 37-01 trial (NCT01796171). In the marginal zone lymphoma arm of the trial (n = 9), 177Lu lilotomab satetraxetan resulted in a 78% overall response rate and a 44% complete response.3
Last month, 177Lu lilotomab satetraxetan received a positive opinion from the European Medicines Agency (EMA) for an orphan drug designation application in the same indication; the Lymphoma Hub’s coverage can be found here. 177Lu lilotomab satetraxetan has also 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.4
References
- Nanovector N. Nordic Nanovector's Betalutin® Receives fast-track designation from US FDA for marginal zone lymphoma. PRNewswire. https://www.prnewswire.com/news-releases/nordic-nanovectors-betalutin-receives-fast-track-designation-from-us-fda-for-marginal-zone-lymphoma-301084836.html. Published Jun 29, 2020. Accessed Jun 29, 2020.
- 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:2967/jnumed.119.237230
- A Kolstad, U Madsbu, M Beasley et al. LYMRIT-37-01: A phase I/II study of 177Lu-lilotomab satetraxetan antibody-radionuclide conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL): Analysis with 6 month follow-up. Poster #2879. 60th Annual Meeting of the American Society of Hematology; Dec 1–4, 2018; San Diego, US.
- 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 Jun 29, 2020.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
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