FDA — authorised 23 October 2025
- Application: BLA761440
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: BLENREP
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Arm A: Belantamab Mafodotin in United States
FDA authorised Arm A: Belantamab Mafodotin on 23 October 2025
Marketing authorisation
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 United States
Frequently asked questions
Is Arm A: Belantamab Mafodotin approved in United States?
Yes. FDA authorised it on 23 October 2025.
Who is the marketing authorisation holder for Arm A: Belantamab Mafodotin in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.