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Blenrep

belantamab mafodotin
BCMA-Directed ADCFDA Approved 2024GSK
Route
IV
Half-Life
~3 days
FDA Approved
2024
Manufacturer
GSK
1. Indications and Usage

With bortezomib and dexamethasone for adults with R/R multiple myeloma after 2+ prior lines including a PI and IMiD.

2. Dosage and Administration

2.5 mg/kg IV once every 3 weeks with bortezomib and dexamethasone.

3. Dosage Forms and Strengths

Injection: 100 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Ocular Toxicity: Keratopathy reported. Ophthalmologic exams required at baseline and prior to each dose. Available only through REMS.
  • Thrombocytopenia: Monitor platelet counts.
  • Infusion-Related Reactions: Premedicate and monitor.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Keratopathy (71%), Thrombocytopenia (40%), Blurred Vision (35%), Nausea (28%), Pyrexia (24%), Infusion Reactions (20%), Fatigue (18%)

Keratopathy
71%
Thrombocytopenia
40%
Blurred Vision
35%
Nausea
28%
Pyrexia
24%
Infusion Reactions
20%
Fatigue
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No formal drug interaction studies conducted.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Belantamab mafodotin is a BCMA-targeted ADC conjugated to MMAF that disrupts microtubules and mediates ADCC against BCMA-expressing myeloma cells.

Pharmacokinetics

Half-life (ADC): ~12 days. Clearance: 0.9 L/day. Steady state by Cycle 4.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Belantamab Mafodotin Trials on ClinicalTrials.gov ↗ 📚 PubMed: Belantamab Mafodotin Clinical Trials ↗
FDA-Approved Tumor Types

Blenrep has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Multiple Myeloma
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Blenrep. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Blenrep (belantamab mafodotin) approved for?

Blenrep (belantamab mafodotin) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Blenrep (belantamab mafodotin) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Blenrep (belantamab mafodotin) work?

Belantamab mafodotin is a BCMA-targeted ADC conjugated to MMAF that disrupts microtubules and mediates ADCC against BCMA-expressing myeloma cells.

What are the most common side effects?

Keratopathy (71%), Thrombocytopenia (40%), Blurred Vision (35%), Nausea (28%), Pyrexia (24%), Infusion Reactions (20%), Fatigue (18%) Keratopathy 71% Thrombocytopenia 40% Blurred Vision 35% Nausea 28% Pyrexia 24% Infusion Reactions 20% Fatigue 18%

← All TherapiesFull Prescribing Information ↗