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

“FDA has accepted for review the resubmission of the BLA for odronextamab in R/R follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is  July 30, 2025. Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL (OLYMPIA-1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response. Serious adverse events occurred in 67% of patients; those occurring in ≥10% of patients included cytokine release syndrome, COVID-19 and pneumonia.”