Odronextamab BLA resubmission accepted for FDA review

The US Food and Drug Administration (FDA) has accepted for review Regeneron Pharmaceuticals’ (Nasdaq: REGN) resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (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. The FDA had issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in March last year.

Regeneron explained that acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase III 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 I and pivotal Phase II 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.