Difference between revisions of "Belantamab mafodotin (Blenrep)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916 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 | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916 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 analog 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. |
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| + | ==Toxicity management== | ||
| + | *Use of belantamab mafodotin required participation in the [http://www.blenreprems.com/ Blenrep Risk Evaluation and Mitigation Strategy (REMS) program] until withdrawal from the US market in February 2023. | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==History of changes in FDA indication== | ==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| + | **2023-02-06: Accelerated approval withdrawn.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. ''(Based on DREAMM-2)'' | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[https:// | + | *[https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF Belantamab mafodotin (Blenrep) package insert]<ref>[https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF Belantamab mafodotin (Blenrep) Package Insert]</ref> |
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' GSK-2857916 |
*'''Generic name:''' belantamab mafodotin-blmf | *'''Generic name:''' belantamab mafodotin-blmf | ||
*'''Brand name:''' Blenrep | *'''Brand name:''' Blenrep | ||
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[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category: | + | [[Category:Anti-BCMA antibody-drug conjugates]] |
| − | |||
[[Category:Microtubule inhibitors]] | [[Category:Microtubule inhibitors]] | ||
| + | [[Category:Multiple myeloma medications]] | ||
| + | |||
| + | [[Category:EMA approved in 2020]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:FDA withdrawn in 2023]] | ||
Latest revision as of 18:12, 6 November 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 analog 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 required participation in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program until withdrawal from the US market in February 2023.
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. (Based on DREAMM-2)
Patient drug information
Also known as
- Code name: GSK-2857916
- Generic name: belantamab mafodotin-blmf
- Brand name: Blenrep