Regulatory PathRegulatory requirements compared

Active substance

Belantamab mafodotin

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
BLENREP70MGinjectable · injectionGLAXOSMITHKLINE LLCPrescription23 Oct 2025

EMA European Union — centrally authorised medicines

Blenrep GlaxoSmithKline Trading Services Limited · Authorised · authorised 23 Jul 2025 · ATC L01FX15

Therapeutic indication (EMA)

Blenrep is indicated in adults for the treatment of relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

Blenrep GlaxoSmithKline Trading Services Limited · Expired · authorised 25 Aug 2020 · ATC L01XC39

Therapeutic indication (EMA)

Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
BLENREP0255961770 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSGLAXOSMITHKLINE INC
BLENREP02559625100 MG / VIALPOWDER FOR SOLUTION · INTRAVENOUSGLAXOSMITHKLINE INC

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.