(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