On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial, 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.
This news follows Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) recommending Epkinly® in this indication for reimbursement at its November 2024 meeting.