Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL), following its approval for R/R diffuse large B-cell lymphoma (DLBCL) in 2023. Full market approval will be contingent upon further trials confirming the drug’s efficacy.
The FDA filing was supported by the Phase I/II EPCORE NHL-1 study, which included 127 adult patients with R/R FL who had previously received a median of three lines of therapy, with 70% of patients having double refractory disease. The study demonstrated an overall response rate (ORR) of 82% and a complete response (CR) rate of 60%, including 67% of patients achieving minimal residual disease (MRD) negativity. Moreover, over half of the patients who responded to the treatment were still responsive at the time of data analysis, indicating a median duration of response (DoR) that was not reached at a median follow-up of 14.8 months.
AbbVie and Genmab initiated their partnership in 2020, with Genmab leveraging its expertise in antibody discovery and development. According to the terms of their agreement, the companies will share commercial responsibilities in the U.S. and Japan, while AbbVie will lead global commercialization efforts.- Flcube.com
