On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.
Epkinly® (marketed as Tepkinly® in the EU) was co-developed by Genmab and AbbVie, and the companies share commercial responsibilities in the US and Japan.
In January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This followed provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.