COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), marking it as the first subcutaneous bispecific T-cell engager approved for this patient population in Europe.
The approval follows a 2020 deal between Genmab and US pharmaceutical giant AbbVie (NYSE: ABBV), which saw the two companies co-developing up to three bispecific T-cell engager candidates globally. The agreement included a substantial upfront payment of USD 750 million and potential milestone payments of up to USD 3.15 billion to Genmab. The drug has already received two approvals from the US FDA, first for R/R DLBCL in May 2023 and later for third-line treatment of R/R FL in February this year.
The EC’s conditional approval was supported by data from the Phase I/II EPCORE NHL-1 clinical trial, which demonstrated an overall response rate (ORR) of 83% and a complete response (CR) rate of 63% in patients treated with Tepkinly. The median duration of response was 21.4 months, indicating a promising therapeutic effect. The drug’s administration mechanism, designed to mitigate cytokine release syndrome (CRS), resulted in no Grade 3 or higher CRS cases.
This regulatory milestone underscores Genmab’s commitment to expanding access to innovative therapies for patients with difficult-to-treat lymphomas and strengthens its position in the global oncology market.- Flcube.com
