The European Medicines Agency (EMA) has recommended granting marketing authorization for epcoritamab, a monoclonal antibody for treating relapsed or refractory follicular lymphoma (FL). This recommendation is based on positive Phase 1/2 EPCORE NHL-1 clinical trial results.
Epcoritamab is administered subcutaneously and demonstrated significant efficacy in patients with FL who had previously undergone multiple lines of therapy. The study included patients resistant to anti-CD20 antibody and alkylating agent treatments.
The most common side effects observed with epcoritamab were cytokine release syndrome (CRS), injection site reactions, and infections. To mitigate the risk of CRS, an optimized step-up dosing schedule was developed and evaluated, resulting in a lower incidence and severity of CRS.
The positive EMA opinion recognizes the unmet medical need for patients with difficult-to-treat FL. Epcoritamab offers a potential new therapeutic option for these patients.
“The EMA’s positive opinion is a significant step forward in providing a new treatment option for patients with relapsed or refractory follicular lymphoma,” said Jan van de Winkel, CEO of Genmab.
The European Commission will decide on epcoritamab’s authorization later this year. If approved, epcoritamab will be Europe’s first T-cell-engaging bispecific antibody for treating FL.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
