Blenrep (belantamab mafodotin)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- belantamab mafodotin
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Wed 23 Jul 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006511
- ATC
- L01FX15
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
Thu 23 Oct 2025🇺🇸 FDA approval
FDA approves Blenrep (belantamab mafodotin-blmf), a new medicine
Glaxosmithkline Llc; BLA761440; New biologic; injectable · source
Same substance in other markets
- 🇺🇸 Blenrep Approved · Glaxosmithkline Llc
- 🇪🇺 Blenrep Expired · GlaxoSmithKline Trading Services Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.