Genmab (GMAB) said Monday that the European Commission approved Tepkinly in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma.
The approval was backed by the phase 3 trial, in which the combination reduced the risk of disease progression or death by 79% and achieved a 96% overall response rate, versus 81% for lenalidomide and rituximab alone.
Genmab said the combination is the first bispecific antibody-based therapy approved in Europe for second-line relapsed or refractory follicular lymphoma and offers a chemotherapy-free treatment option.