Genmab A/S(GMAB) said that the U.S. Food and Drug Administration approved EPKINLY (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma or FL after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s).
Epcoritamab (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. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.
Genmab and AbbVie said they continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies.
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