Genmab A/S announced its intention to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2025. The sBLA is for subcutaneous epcoritamab in combination with rituximab and lenalidomide (R2) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one prior systemic therapy.
This decision is supported by positive topline results from the Phase 3 EPCORE FL-1 trial, which evaluated epcoritamab plus R2 versus R2 alone. An interim analysis by an Independent Data Monitoring Committee confirmed that the study met one of its dual primary endpoints, achieving a statistically significant overall response rate (ORR) with a p-value < 0.0001.
The safety profile of the epcoritamab plus R2 combination was consistent with the known safety profiles of the individual regimens, with no new safety signals observed. This milestone represents a significant advancement in the development of epcoritamab as a potential treatment for R/R FL patients.
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