FDA grants fast track status to Betalutin for marginal zone lymphoma
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The FDA granted fast track designation to 177Lu lilotomab satetraxetan for the treatment of adults with relapsed or refractory marginal zone lymphoma who received at least two prior systemic therapies.
Results of the phase 1/phase 2 LYMRIT 37-01 trial showed a promising clinical effect with 177Lu lilotomab satetraxetan (Betalutin, Nordic Nanovector) — a next-generation radioimmunoconjugate — in a small cohort of patients with marginal zone lymphoma, a rare form of non-Hodgkin lymphoma.
The trial included 74 patients (median age, 68 years; median number of prior therapies, 3; range, 1-9) with lymphoma, including nine with marginal zone lymphoma.
Patients received 177Lu lilotomab satetraxetan once daily. Researchers reported a 78% overall response rate and a 44% complete response rate; both were the highest rates of any patient subgroup in the study.
“We are very pleased to receive fast track designation for Betalutin in marginal zone lymphoma, which recognizes the clear need for new therapeutic options for patients with advanced [disease] who no longer respond to the therapies they have been receiving,” Lars Nieba, interim CEO of Nordic Nanovector, said in a company-issued press release.
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