Genmab to submit FDA application for lymphoma therapy
Ella Day | May 2, 2025 | News story | Research and Development | AbbVie, Biologics License Application, FDA, Genmab, Oncology, epcoritamab, lymphoma, therapeutics
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for epcoritamab, targeting the treatment of adults with relapsed or refractory (R/R) follicular lymphoma. The move, in collaboration with AbbVie, marks a significant step toward the international development of the therapy.
Epcoritamab is being evaluated in combination with rituximab and lenalidomide (R2). The decision to submit the sBLA is supported by positive interim results from the phase 3 EPCORE FL-1 trial, which compared epcoritamab plus R2 with R2 alone in adult patients with R/R follicular lymphoma. The study met one of its dual primary endpoints, and the safety profile was consistent with the known effects of the individual treatments. No new safety signals were observed.
“These interim topline results demonstrate the potential of this investigational epcoritamab combination regimen,” said Jan van de Winkel, CEO of Genmab.
Epcoritamab is a subcutaneously administered IgG1-bispecific antibody that redirects cytotoxic T-cells to target malignant B-cells. It is a key asset for Genmab, which specialises in antibody-based cancer therapies.
Full trial results are expected to be submitted later this year for presentation at a medical congress and shared with global regulatory bodies.
“This milestone represents our commitment to the continued development of epcoritamab alongside our partner, AbbVie,” van de Winkel added.
Ella Day
2/5/25
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