Blenrep (belantamab mafodotin)
OrphanPRIMEConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- belantamab mafodotin
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Expired
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Tue 25 Aug 2020
- Designations
- Orphan, PRIME, Conditional, Additional monitoring
- Application
- EMEA/H/C/004935
- ATC
- L01XC39
- Official record
- www.ema.europa.eu
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.
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 Authorised · GlaxoSmithKline Trading Services Limited
- 🇺🇸 Blenrep Approved · Glaxosmithkline Llc
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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.