Regeneron lymphoma therapy accepted for EU review
Shidlovski

Regeneron (NASDAQ:REGN) announced Thursday that the European Medicines Agency (EMA) accepted its marketing application for the bispecific antibody odronextamab to review it as a late-line option for adults with lymphoma, a cancer of the lymphatic system.
Regeneronâs (REGN) marketing authorization application (MAA) for odronextamab targets adults with relapsed or refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma who have received at least two prior lines of therapy.

The MAA is backed by data from REGNâs pivotal Phase 1 and 2 trials, ELM-1 and ELM-2, respectively, designed to evaluate odronextamab in FL and DLBCL. The two types of cancer are considered the most common forms of B-cell non-Hodgkin lymphoma.
Odronextamab is also under investigation as an earlier-line therapy and for other types of B-NHL. 



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