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Belantamab mafodotin
Belantamab mafodotin, sold under the brand name Blenrep, is a monoclonal antibody conjugated with a cytotoxic agent for the treatment of relapsed and refractory multiple myeloma. Belantamab mafodotin is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate.
The most common adverse reactions include keratopathy (corneal epithelium change on eye exam), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
Belantamab mafodotin is a humanized IgG1κ monoclonal antibody against the B-cell maturation antigen (BCMA) conjugated with a cytotoxic agent, maleimidocaproyl monomethyl auristatin F (mcMMAF). The antibody-drug conjugate binds to BCMA on myeloma cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.
Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020. The US Food and Drug Administration considers it to be a first-in-class medication.
In the EU, belantamab mafodotin is indicated for the treatment of adults with relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in people who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone in people who have received at least one prior therapy including lenalidomide.
In the US, belantamab mafodotin is indicated for use in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The US prescribing information includes a boxed warning stating belantamab mafodotin causes changes in the corneal epithelium resulting in alterations in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes. Among those receiving belantamab mafodotin in DREAMM-7, ocular toxicity occurred in 92% of participants, including grade 3 or 4 in 77%, with 83% requiring dosage modification due to ocular toxicity. Because of the risk of ocular toxicity, belantamab mafodotin is available in the US only through a risk evaluation and mitigation strategy (REMS), called the BLENREP REMS. Other warnings and precautions include thrombocytopenia and embryo-fetal toxicity.
Belantamab mafodotin was evaluated in DREAMM-2 (NCT03525678), an open-label, multi-center trial. Participants received either belantamab mafodotin, 2.5 mg/kg or 3.4 mg/kg intravenously, once every three weeks until disease progression or unacceptable toxicity.
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Belantamab mafodotin
Belantamab mafodotin, sold under the brand name Blenrep, is a monoclonal antibody conjugated with a cytotoxic agent for the treatment of relapsed and refractory multiple myeloma. Belantamab mafodotin is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate.
The most common adverse reactions include keratopathy (corneal epithelium change on eye exam), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
Belantamab mafodotin is a humanized IgG1κ monoclonal antibody against the B-cell maturation antigen (BCMA) conjugated with a cytotoxic agent, maleimidocaproyl monomethyl auristatin F (mcMMAF). The antibody-drug conjugate binds to BCMA on myeloma cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.
Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020. The US Food and Drug Administration considers it to be a first-in-class medication.
In the EU, belantamab mafodotin is indicated for the treatment of adults with relapsed or refractory multiple myeloma: in combination with bortezomib and dexamethasone in people who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone in people who have received at least one prior therapy including lenalidomide.
In the US, belantamab mafodotin is indicated for use in combination with bortezomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The US prescribing information includes a boxed warning stating belantamab mafodotin causes changes in the corneal epithelium resulting in alterations in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes. Among those receiving belantamab mafodotin in DREAMM-7, ocular toxicity occurred in 92% of participants, including grade 3 or 4 in 77%, with 83% requiring dosage modification due to ocular toxicity. Because of the risk of ocular toxicity, belantamab mafodotin is available in the US only through a risk evaluation and mitigation strategy (REMS), called the BLENREP REMS. Other warnings and precautions include thrombocytopenia and embryo-fetal toxicity.
Belantamab mafodotin was evaluated in DREAMM-2 (NCT03525678), an open-label, multi-center trial. Participants received either belantamab mafodotin, 2.5 mg/kg or 3.4 mg/kg intravenously, once every three weeks until disease progression or unacceptable toxicity.