Genmab (GMAB) and partner AbbVie (NYSE:ABBV) have received U.S. FDA approval for their monoclonal antibody Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma.
The approval is based on results from Phase 1/2 EPCORE NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with relapsed or refractory follicular lymphoma after two or more lines of prior therapy.
This indication was approved under FDA’s accelerated approval program based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s).
With this approval, Epkinly becomes the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population.
Epcoritamab (an IgG1-bispecific antibody) – approved under the brand name Epkinly in the U.S. and Japan, and Tepkinly in the EU – has received regulatory approval in certain lymphoma indications in several territories. The drug is being co-developed by Genmab (GMAB) and AbbVie (ABBV) as part of the companies’ oncology collaboration.
The duo continues to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. They will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
