CHMP Backs Odronextamab For EU Approval In Treating Tough Lymphoma Cases

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending conditional marketing authorization for odronextamab. This authorization is aimed at treating 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. The European Commission is expected to make a final decision in the coming months.

FL and DLBCL are the two most prevalent subtypes of B-cell non-Hodgkin lymphoma (B-NHL). FL is a slow-growing, yet incurable disease, with most patients relapsing after initial treatment. DLBCL is a more aggressive subtype, with up to 50% of high-risk patients experiencing disease progression after first-line treatment, either relapsing or becoming refractory to treatment. Annually, approximately 120,000 cases of FL and 163,000 cases of DLBCL are diagnosed worldwide, with around 15,000 FL cases and 31,000 DLBCL cases occurring in Europe each year.

The positive opinion from CHMP is based on results from the Phase 1 ELM-1 and pivotal Phase 2 ELM-2 trials, which showed robust and durable response rates and an acceptable safety profile for odronextamab in adults with R/R FL or R/R DLBCL. In the pooled safety population, the most common serious adverse reactions included cytokine release syndrome, pneumonia, COVID-19, and fever. Previously, the EMA granted odronextamab Orphan Designation for both FL and DLBCL. Odronextamab is currently under clinical development and has not yet been approved by any regulatory authority.

Regeneron is continuing to explore the use of odronextamab both as a monotherapy and in combination with other treatments for earlier lines of therapy in difficult-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program (one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and other B-NHLs), and early-stage trials with chemotherapy-free combinations.