Loncastuximab tesirine granted priority review status by the FDA

On November 20, 2020, the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for loncastuximab tesirine for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which was submitted in September 2020. The FDA have also granted loncastuximab tesirine priority review status with a Prescription Drug User Fee Act target date of May 21, 2021.

The novel CD19-directed antibody–drug conjugate is being investigated for the treatment of patients with DLBCL and mantle cell lymphoma in a number of clinical trials. Data from the single-arm multicenter, open-label, phase II LOTIS 2 trial (NCT03589469), which evaluated the safety and efficacy of loncastuximab tesirine in 145 patients with relapsed or refractory DLBCL who had received ≥ 2 prior lines of systemic therapy, formed the basis of the BLA. Updated results from subgroup analyses of the LOTIS 2 trial will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday, December 5, 2020 (abstract #1183).