On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The approval is subject to AbbVie providing further clinical data by 21 December 2026, unless otherwise agreed with Medsafe.
This news follows provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.