FDA grands second approval for AbbVie’s EPKINLY in follicular lymphoma Genmab

AbbVie (ABBV) “announced that the FDA has approved EPKINLY, or epcoritamab-bysp, as the first and only T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of prior therapy. This indication is approved under the 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 trial(s). Epcoritamab is being co-developed by AbbVie and Genmab (GMAB) 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.”