Primary-source record
Decision-gradeEMA opinion
Genmab: TEPKINLY + R2 approved by EC for 2L R/R follicular lymphoma
The European Commission granted marketing authorization for TEPKINLY (epcoritamab) plus lenalidomide and rituximab in relapsed or refractory follicular lymphoma after one prior line. This is the first bispecific-based regimen approved in Europe for second-line FL and provides a fixed-duration, chemotherapy-free option. The approval is supported by the Phase 3 EPCORE FL-1 trial showing a 79% reduction in risk of progression or death versus R2 alone.
Key facts
- Filed
- Jul 6, 2026, 05:59 PM
- Event
- EMA opinion
- Direction
- Positive
- Company
GMABGenmab- Asset
- epcoritamab
- Source
- Company press release
- Confidence
- Sourced
- CR
- 74% vs 43%
- HR
- 0.21
- ORR
- 96% vs 81%
Source excerpt
Genmab Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma Media Release COPENHAGEN, Denmark; July 6, 2026 TEPKINLY ® (epcoritamab) plus lenalidomide and rituximab (R 2 ) 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 + R 2 demonstrated significantly superior progression-free survival and overall response rates compared to R 2 , 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 + R 2 ) 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 + R 2 compared to standard of care R 2 . “Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology de
