Marginal zone lymphoma treatment granted FDA fast track designation

The U.S. Food and Drug Administration has granted fast track designation to ¹⁷⁷Lu lilotomab satetraxetan (Betalutin) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received ≥2 prior systemic therapies, according to a press release by Nordic Nanovector ASA.

The treatment is being evaluated in a Phase 1/2a trial which demonstrated a 78% overall response rate and a 44% complete response in patients with MZL.

“We are very pleased to receive Fast-track designation for Betalutin in MZL, which recognizes the clear need for new therapeutic options for patients with advanced MZL patients who no longer respond to the therapies they have been receiving . We are evaluating the opportunity for investigating Betalutin in this important and underserved indication and will provide an update when we have made a decision,” said Lars Nieba, Interim Chief Executive Officer, in a press release.

Read the full press release here.