Genmab’s TEPKINLY + R2 Wins EU Approval As First Bispecific Therapy For Relapsed Follicular Lymphoma Following Phase 3 Trial Success
Genmab A/S
Genmab A/S GMAB | 0.00 |
- TEPKINLY® (epcoritamab) plus lenalidomide and rituximab (R2) is the first and only bispecific-based therapy approved in Europe for the treatment of follicular lymphoma in the second-line setting, offering a chemotherapy-free option
- In the Phase 3 EPCORE® FL-1 trial, fixed-duration TEPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to R2, with approximately three out of four patients achieving a complete response
Genmab A/S (NASDAQ:GMAB) announced today that the European Commission (EC) granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE® FL-1 trial that evaluated fixed-duration TEPKINLY + R2 compared to standard of care R2.
