Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA(R) (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China. The BLA has been granted priority review by the NMPA. The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA.

The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab Tesirine-lpyl) for the treatment of adult patients With relapsed or refractory®? large B-cell lymphoma after two or more line of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma.

The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.