🇪🇺 Arm A: Belantamab Mafodotin in European Union

EMA authorised Arm A: Belantamab Mafodotin on 25 August 2020

Marketing authorisations

EMA — authorised 25 August 2020

  • Application: EMEA/H/C/004935
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Blenrep
  • Indication: 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.
  • Pathway: conditional, orphan, PRIME
  • Status: withdrawn

Read official source →

EMA — authorised 23 July 2025

  • Application: EMEA/H/C/006511
  • Marketing authorisation holder: GlaxoSmithKline Trading Services Limited
  • Local brand name: Blenrep
  • Indication: 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.
  • Status: approved

On 23 July 2025, the European Medicines Agency (EMA) granted marketing authorisation for Belantamab Mafodotin, marketed as Blenrep, for the treatment of relapsed or refractory multiple myeloma in adults. This authorisation was granted to GlaxoSmithKline Trading Services Limited. Blenrep is indicated for use 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.

Read official source →

Arm A: Belantamab Mafodotin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Arm A: Belantamab Mafodotin approved in European Union?

Yes. EMA authorised it on 25 August 2020; EMA authorised it on 23 July 2025.

Who is the marketing authorisation holder for Arm A: Belantamab Mafodotin in European Union?

GlaxoSmithKline Trading Services Limited holds the EU marketing authorisation.