Genmab (GMAB) said late Thursday it plans to submit a supplemental biologics license application in H1 to the US Food and Drug Administration for epcoritamab in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma.
The decision is based on findings from a phase 3 study, which met one of its dual primary endpoints of overall response rate, the company said.
Genmab said the safety of the combination therapy aligned with prior data for the individual drugs, and no unexpected risks were reported.
Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, a cancer that starts in white blood cells.
Shares of the company were up 3% in Friday premarket activity.
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