Zynlonta approved in the EU for the treatment of relapsed or refractory diffuse large B-cell lymphoma. Sobi + ADC Therapeutics
Sobi and ADC Therapeutics SA announced that the European Commission (EC) has granted conditional marketing authorisation for the use of Zynlonta (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The approval follows a positive opinion issued in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).
The approval is based on data from LOTIS-2, a large (n=145) phase II multinational, single-arm clinical study of Zynlonta for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy.
In April 2021, the FDA granted accelerated approval of Zynlonta as the first CD19-targeted antibody drug conjugate as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. In July, Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialise Zynlonta for use in haematology and other indications of large unmet medical need in Europe and most international markets. The license agreement aimed at augmenting Sobi's presence in haematology, one of Sobi's two main disease areas. Zynlonta will be made commercially available alongside other Sobi haematology medicines.
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