The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorisation of odronextamab for the treatment of 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 drug is developed by Regeneron.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorisation of odronextamab for the treatment of 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 drug is developed by Regeneron.
Odronextamab, also known as REGN1979, is a bispecific antibody designed to target CD20 on tumor cells and CD3 on T cells. This dual target helps activate T cells to attack tumor cells. This dual target helps activate T cells to attack and kill tumor cells. It has shown promise in the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma, including patients who have not responded to CAR T-cell therapy.
FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). Despite being a slow-growing subtype, FL is an incurable disease and most patients relapse after initial treatment. DLBCL is an aggressive subtype, and up to 50% of high-risk patients progress after first-line treatment (e.g., relapse or refractoriness to treatment). It is estimated that approximately 120,000 cases of FL and 163,000 cases of DLBCL are diagnosed worldwide every year. In Europe, it is estimated that approximately 15 thousand cases of FL and 31 thousand cases of DLBCL are diagnosed every year.
The CHMP’s positive opinion is supported by the results of the Phase 1 ELM-1 and Phase 2 ELM-2 studies, which demonstrated robust and durable response rates and an acceptable safety profile of odronextamab in adults with FL or DLBCL R/ R. In a pooled safety population, the most common serious adverse reactions were cytokine release syndrome, pneumonia, COVID-19, and pyrexia.
The EMA previously granted orphan drug designation to odronextamab for both FL and DLBCL. Odronextamab is currently in clinical development and has not been approved by any regulatory authority.
Regeneron continues to evaluate the use of odronextamab as monotherapy and in combination with prior lines of therapy in difficult-to-treat lymphomas. This includes the pivotal ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, one of the largest clinical programs in lymphoma evaluating odronextamab in prior lines of therapy and in other B-NHL, as well as early-stage studies with chemotherapy-free combinations.
