Danish biotechnology company Genmab A/S (CPH:GMAB) announced on Friday a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for epcoritamab (TEPKINLY) as a monotherapy for relapsed/refractory follicular lymphoma (FL) after multiple prior therapies.

If approved, epcoritamab would be the first such bispecific antibody for both FL and diffuse large B-cell lymphoma (DLBCL) in the European Union.

"Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis," said Genmab CEO Jan van de Winkel, Ph.D. "This positive opinion recognises the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option."

The final decision from the European Commission is expected later this year.