Difference between revisions of "Belantamab mafodotin (Blenrep)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*8/5/2020: Approved 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)'' | *8/5/2020: Approved 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)'' | ||
+ | ==History of changes in EMA indication== | ||
+ | *8/25/2020: Initial conditional approval | ||
==Patient drug information== | ==Patient drug information== |
Revision as of 02:24, 31 December 2022
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
- 8/5/2020: Approved 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)
History of changes in EMA indication
- 8/25/2020: Initial conditional approval
Patient drug information
Also known as
- Code name: GSK2857916
- Generic name: belantamab mafodotin-blmf
- Brand name: Blenrep