Difference between revisions of "Belantamab mafodotin (Blenrep)"
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Revision as of 21:09, 30 June 2023
Mechanism of action
From the NCI Drug Dictionary: An antibody-drug conjugate (ADC) consisting of belantamab, an afucosylated, humanized monoclonal antibody, directed against the B-cell maturation antigen (BCMA), conjugated to mafodotin, an auristatin analogue and microtubule inhibitor monomethyl auristatin phenylalanine (MMAF), with potential antineoplastic activity. Upon administration of belantamab mafodotin, the anti-BCMA antibody moiety selectively binds to BCMA on tumor cell surfaces. Upon internalization, the MMAF moiety binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces tumor cell apoptosis. In addition, belantamab mafodotin-blmf induces antibody-dependent cellular cytotoxicity (ADCC). Altogether, this results in the inhibition of cellular proliferation in tumor cells that overexpress BCMA.
Toxicity management
- Use of belantamab mafodotin requires participation in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program.
Diseases for which it is used
History of changes in FDA indication
- 2020-08-05: Accelerated approval for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. (Based on DREAMM-2)
- 2023-02-06: Accelerated approval withdrawn. (Based on DREAMM-3)
History of changes in EMA indication
- 2020-08-25: Initial conditional approval as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Patient drug information
Also known as
- Code name: GSK2857916
- Generic name: belantamab mafodotin-blmf
- Brand name: Blenrep