BLA submitted to FDA for loncastuximab tesirine in relapsed/refractory DLBCL

On September 21, 2020, a Biologics Licence Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) for loncastuximab tesirine for the treatment of patients with relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL).¹

Loncastuximab tesirine is a novel CD19 targeted antibody–drug conjugate, currently being evaluated in clinical trials for patients with DLBCL and mantle cell lymphoma. The BLA submission is based on data from the single-arm multicenter, open-label, phase II LOTIS 2 trial (NCT03589469) evaluating the safety and efficacy of loncastuxmab tesirine in 145 patients with R/R DLBCL who have received ≥ 2 prior lines of systemic therapy. The data, presented at the 25^th congress of the European Hematology Association (EHA) in June 2020, showed an overall response rate of 48.3%, complete response rate of 24.1%, and a manageable tolerability profile for patients treated with loncastuximab tesirine (for an overview of the trial data, see an interview with the EHA congress presenter on the Lymphoma Hub).

If approved, loncastuximab tesirine could help to address an unmet clinical need for patients with DLBCL who have not responded to prior chemotherapies or relapsed from stem cell transplant.