EMA Issues Positive Opinion on Loncastuximab Tesirine for DLBCL

The Committee for Medicinal Products for Human Use (CHMP) of the ​European Medicines Agency (EMA) has issued a positive opinion recommending the Marketing Authorization of loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The opinion is based on data from the phase II, multinational, single-arm LOTIS-2 trial, assessing loncastuximab tesirine 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 loncastuximab tesirine 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 September 2021, the EC granted it Orphan Drug Designation for the treatment of DLBCL.

Source: Business Wire, September 2022