European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The final European Commission decision on this indication for Tepkinly is anticipated later this year.
FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.
