BLENREP

What it is

Belantamab mafodotin is an antibody-drug conjugate (ADC) that contains belantamab, an afucosylated humanised monoclonal IgG1κ antibody specific for B cell maturation antigen (BCMA), conjugated with maleimidocaproyl monomethyl auristatin F (mcMMAF). BLENREP is supplied as powder for injection in vials containing 70 mg or 100 mg of belantamab mafodotin.

Approved indications

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma: — in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy — in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide

Dosing overview

Belantamab mafodotin is administered as an intravenous infusion over approximately 30 minutes. Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.

Key safety warnings

BLENREP can cause changes in the corneal epithelium which may result in ocular symptoms such as changes in vision and dry eyes. Severe visual impairment and/or corneal ulcers can occur. Ophthalmic exams should be conducted prior to each dose of BLENREP or more frequently as clinically indicated. Patients should administer preservative-free artificial tears at least 4 times a day beginning on the first day of infusion and continuing until completion of treatment as this may reduce ocular symptoms. Thrombocytopenic events (thrombocytopenia and platelet count decreased) were reported with belantamab mafodotin. Thrombocytopenia may lead to serious bleeding events, including gastrointestinal and intracranial bleeding. Complete blood counts should be obtained at baseline and monitored during treatment, as clinically indicated. Cases of pneumonitis, including fatal events, have been observed with belantamab mafodotin although a casual association has not been established. Evaluation of patients with new or worsening unexplained pulmonary symptoms (e.g., cough, dyspnoea) should be performed to exclude possible pneumonitis. Hepatitis B virus (HBV) reactivation can occur in patients treated with BLENREP, and in some cases, may result in fulminant hepatitis, hepatic failure, and death. Patients with evidence of positive HBV serology must be monitored for clinical and laboratory signs of HBV reactivation as per clinical guidelines.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

No information regarding PBS listing is available in the provided source documents.

Regulatory history

BLENREP was first registered on the ARTG on 2025-11-17 and 2025-11-18, with two vial strengths listed (100 mg and 70 mg powder for injection). The TGA approved BLENREP on 2025-11-12 for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone or in combination with pomalidomide and dexamethasone. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.