The European Commission (EC) has granted conditional marketing authorisation for Sobi and ADC Therapeutics’ Zynlonta (loncastuximab tesirine) to treat relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
In September this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use provided a positive opinion for granting the authorisation.
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The latest development is based on the findings from the multinational, single-arm Phase II LOTIS-2 clinical trial of Zynlonta to treat r/r DLBCL in adults who have received two or more lines of systemic treatment previously.
With the approval, the treatment is intended for use in all member states of the European Union, Norway, Liechtenstein and Iceland.
Sobi Research & Development and Medical Affairs head, and chief medical officer Anders Ullman said: “We look forward to making Zynlonta available as a new treatment option to patients in the EU impacted by diffuse large B-cell lymphoma, a debilitating disease in haematology.”
The US Food and Drug Administration approved Zynlonta under an accelerated pathway in April last year for the same indication.
A CD19-directed antibody-drug conjugate, Zynlonta attaches to a CD19-expressing cell. It is subsequently internalised by the cell, where enzymes then release a pyrrolobenzodiazepine payload.
The payload attaches to deoxyribonucleic acid (DNA) minor groove with minimum distortion, making it less noticeable to DNA repair mechanisms. This causes the stoppage of cell cycle and death of tumour cells.
Sobi and ADC entered an exclusive licence agreement in July this year for the development and marketing of Zynlonta for haematology and other indications with unmet medical needs in Europe and other global markets.
