REG-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
Genmab announced that the European Commission granted marketing authorization for TEPKINLY in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma, marking the first bispecific-based therapy approved in Europe for this second-line setting. The approval is supported by Phase 3 EPCORE FL-1 trial data demonstrating a 79% reduction in the risk of disease progression or death and an overall response rate of 96% compared to standard of care.
Key figures
- Drug Name
- TEPKINLY (epcoritamab)
- Phase Of Trial
- Phase 3
- Cr control arm
- 43%
- Orr control arm
- 81%
- Cr treatment arm
- 74%
- Pfs hazard ratio
- 0.21
- Orr treatment arm
- 96%
- Pfs risk reduction
- 79%
- Serious adverse reactions rate
- 44%
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