Odronextamab receives positive CHMP opinion for the treatment of adult patients with R/R FL and R/R DLBCL

On June 28, 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of odronextamab, a CD20xCD3 bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who progress after ≥2 lines of systemic therapy. This announcement is based on key results from the phase I ELM-1 (NCT02290951) and phase II ELM-2 (NCT03888105) clinical trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab in adults with R/R FL or R/R DLBCL. The most common serious adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and pyrexia.