BLENREP
BLENREP (belantamab mafodotin-blmf) is an antibody-drug conjugate indicated for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma. This therapeutic regimen is intended for patients who have already received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. By targeting specific proteins on cancer cells, the drug provides a specialized treatment option for advanced stages of the disease.
How BLENREP Works
Belantamab mafodotin-blmf is an antibody-drug conjugate that targets the B-cell maturation antigen (BCMA) found on multiple myeloma cells. After binding to BCMA, the drug is internalized and releases a cytotoxic microtubule inhibitor that disrupts the cell's internal structure, leading to cell cycle arrest and apoptosis. The drug also facilitates tumor cell destruction through immune-mediated mechanisms, specifically antibody-dependent cellular cytotoxicity and phagocytosis.
Details
- Status
- Prescription
- First Approved
- 2025-10-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BLENREP Approval History
What BLENREP Treats
1 indicationsBLENREP is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
BLENREP Boxed Warning
OCULAR TOXICITY • BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred [see Warnings and Precautions ( 5.1 )] . • Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modif...
WARNING: OCULAR TOXICITY • BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred [see Warnings and Precautions ( 5.1 )] . • Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )] . • Because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions ( 5.2 )] . WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred. ( 5.1 ) • Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity. ( 2.3 , 5.1 ) • BLENREP is available only through a restricted program, called the BLENREP Risk Evaluation and Mitigation Strategy (REMS). ( 5.2 )
BLENREP Target & Pathway
ProTarget
A protein highly expressed on malignant plasma cells in multiple myeloma. BCMA-targeted therapies, including CAR-T cells and bispecific antibodies, can eliminate myeloma cells while sparing most normal immune cells.
BLENREP Competitors
Pro3 other drugs also target BCMA. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BCMA). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to BLENREP
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BLENREP FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. BLENREP, a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate, 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 ...
WARNING: OCULAR TOXICITY • BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred [see Warnings and Pre...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.