Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma

Core Viewpoint - Regeneron Pharmaceuticals has resubmitted the Biologics License Application (BLA) for odronextamab to the FDA for the treatment of relapsed/refractory follicular lymphoma, with a decision expected by July 30, 2025 [1][2]. Group 1: FDA Review and Clinical Trials - The FDA accepted the BLA resubmission after Regeneron met the enrollment target for the Phase 3 trial (OLYMPIA-1), which was the only issue identified in the previous submission [2]. - Data from Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2) showed an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response [2]. - Serious adverse events were reported in 67% of patients, with cytokine release syndrome, COVID-19, and pneumonia being the most common [2]. Group 2: Product Information and Market Context - Odronextamab is already approved in the EU as Ordspono™ for treating R/R FL or diffuse large B-cell lymphoma after two or more lines of therapy [3]. - Follicular lymphoma (FL) is a common subtype of B-cell non-Hodgkin lymphoma, with approximately 122,000 cases diagnosed globally each year and over 13,600 cases expected in the U.S. in 2025 [4]. Group 3: Clinical Development Program - The clinical development program for odronextamab includes ongoing trials (ELM-1 and ELM-2) investigating its safety and efficacy across various B-NHL subtypes [5][6]. - The primary endpoint for these trials is the objective response rate, with secondary endpoints including complete response and overall survival [6]. - Odronextamab is being evaluated both as a monotherapy and in combination with other therapies in multiple Phase 3 trials [7]. Group 4: Company Overview - Regeneron is a leading biotechnology company focused on developing medicines for serious diseases, leveraging over three decades of expertise in biology and proprietary technologies [12][13]. - The company is known for its innovative approaches in blood cancer research, particularly in bispecific antibodies and other therapeutic modalities [9].