The European Medicines Agency has accepted for review the Marketing Authorization Application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
