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
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.
“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 department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option.”
