Genmab announces Epkinly combination approved by FDA for lymphoma

Genmab (GMAB) announced that Epkinly in combination with rituximab and lenalidomide was approved by the U.S. Food and Drug Administration for adult patients with relapsed or refractory follicular lymphoma. EPKINLY + R2 was previously granted Breakthrough Therapy Designation by the FDA for the treatment of R/R FL. This designation is granted to investigational medicines for serious or life-threatening diseases in cases where preliminary clinical evidence shows that the therapy may provide substantial improvements over available therapies. 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. “The FDA approval of EPKINLY + R2 is an important advancement for patients with follicular lymphoma, enabling treatment at initial recurrence when more effective intervention is needed,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “This milestone also underscores EPKINLY’s potential as the core therapy for B-cell malignancies, demonstrating benefit in combination and earlier disease, and building on its established role as a single agent option in later lines of treatment.”