Posted by Michael Wonder on 22 Sep 2020
ADC Therapeutics submits biologics license application to the U.S. FDA for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
21 September 2020 - Submission based on efficacy and safety data from LOTIS 2 clinical trial.
ADC Therapeutics today announced the submission of a biologics license application to the U.S. FDA for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following ≥2 lines of prior systemic therapy.
