FDA accepts BLA and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma.- ADC Therapeutics

ADC Therapeutics announced that the FDA has accepted its Biologics License Application (BLA) for Lonca (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021. The BLA submission is based on data from LOTIS 2, the pivotal Phase II multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6th cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade greater than 3 treatment-emergent adverse events in greater than 10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%). Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) Annual Meeting on Saturday, December 5, 2020..