Last reviewed · How we verify
Blenrep (BELANTAMAB MAFODOTIN)
Belantamab mafodotin binds to BCMA on multiple myeloma cells, is internalized, and releases a cytotoxic agent that disrupts microtubules, causing cell death.
At a glance
| Generic name | BELANTAMAB MAFODOTIN |
|---|---|
| Sponsor | GSK |
| Target | BCMA |
| Modality | Antibody drug conjugate |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 300 |
Mechanism of action
Belantamab mafodotin is an antibody-drug conjugate that targets BCMA, a protein found on multiple myeloma cells. Once bound, the drug is taken inside the cell where it releases a toxic agent that interferes with the cell's internal structure, stopping cell division and leading to cell death. It also enhances immune cell-mediated killing of tumor cells.
Approved indications
- Relapsed or Refractory Multiple Myeloma
Boxed warnings
- 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 )
Common side effects
- Keratopathy
- Decreased visual acuity
- Nausea
- Blurred vision
- Pyrexia
- Infusion-related reactions
- Fatigue
- Platelets decreased
- Lymphocytes decreased
- Hemoglobin decreased
- Neutrophils decreased
- Creatinine increased
Key clinical trials
- Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma (PHASE1,PHASE2)
- Study of Belantamab Mafodotin as Pre- and Post-autologous Stem Cell Transplant and Maintenance for Multiple Myeloma (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis (PHASE2)
- Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma (PHASE2)
- Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients (PHASE2)
- Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma (PHASE2)
- A Study of Belantamab Mafodotin in Combination With Nirogacestat and Pomalidomide in People With Multiple Myeloma That Has Not Responded to Treatment or Has Come Back After Treatment (PHASE1)
- Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |