Treats relapsed or refractory multiple myeloma. BLA 761440, held by Glaxosmithkline LLC. Belantamab Mafodotin-Blmf.
As of Nov 13, 2026, BLA 761440 (Blenrep), held by Glaxosmithkline LLC, was first approved by FDA on Oct 23, 2025, with 0 approved supplements and 1 published complete response letter.
BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2025 | Original applicationNew active ingredient · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 23, 2025 | Blenrep (belantamab mafodotin-blmf) | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Blenrep70MG · injectable;injection | Belantamab Mafodotin-Blmf | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
