28 June 2024 - Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and durable response rates in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
Regeneron Pharmaceuticals today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.