The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended the conditional marketing authorization (CMA) of odronextamab for the treatment of relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, according to a press release from Regeneron, the manufacturer of the drug.
The positive opinion is based on results from the ongoing phase I ELM-1 and phase II ELM-2 trials, in which odronextamab, an investigational CD20 × CD3 bispecific antibody, displayed durable response rates and an acceptable safety profile. Cytokine release syndrome, pneumonia, COVID-19, and pyrexia were the most common serious adverse events.
The recommendation comes two years after the EMA granted orphan designation to odronextamab for FL and DLBCL. A decision by the European Commission regarding the CMA is expected to be announced in the coming months.