Genmab A/S announced that EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R R) follicular lymphoma (FL). Genmab Announces EPKINLY (epCoritamab-bysp), in combination with Rituximab and Lenalidomide Approved by the U.S. food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma. Today's milestone marks meaningful progress for people living with follicular lymphoma.
In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R R FL following two or more lines of systemic therapy. With the results from the confirmatory Phase 3 EPCORE FL-1 study, the FDA has also converted the accelerated approval into a full approval. Genmab Announces EP KINLY (epcoritAMab-bysp) in Combination with Rituximab & Lenalidomide Approval by the U.S.Food and Drug Administration for the treatment of Relapsed or Refractories Follicular Lymphoma Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death.
Genmab announced EPKINLY (ep Corituximab-bysp) inCombination with Rituximib and Lenalidomide approved by the U.S., Food and Drug Administration for the Treatment the Treatment of Relapsed or refractory Follicular L lymphoma for 4 months after the last dose of EPKINLY. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets.
