Loncastuximab tesirine receives positive CHMP opinion for the treatment of relapsed or refractory diffuse large B-cell lymphoma
Sobi and ADC Therapeutics SA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a debilitating orphan disease in haematology
The positive opinion from the CHMP is now referred to the European Commission for a decision.
The opinion is based on data from LOTIS-2, a large (n=145) phase II multinational, single-arm clinical study of loncastuximab tesirine as single agent 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 to loncastuximab tesirine-lpyl as the first and only 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 September 2021, the European Commission granted orphan designation to loncastuximab tesirine for the treatment of DLBCL.
In July 2022, Sobi announced an exclusive license agreement with ADC Therapeutics SA to develop and commercialise loncastuximab tesirine for use in haematology and other indications of large unmet medical need in Europe and most international markets. The license agreement for loncastuximab tesirine aimed at augmenting Sobi's presence in orphan diseases within haematology, one of Sobi's main disease areas.
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