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Belantamab mafodotin

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Belantamab mafodotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetB-cell maturation antigen (BCMA) (CD269)
Clinical data
Trade namesBlenrep
Other namesbelantamab mafodotin-blmf, GSK2857916
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC6484H10008N1728O2030S44. (C49H66N6O11)4

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.[2][5][6][3]

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.[2][5]

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).[3] The antibody-drug conjugate binds to BCMA on myeloma cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.[3]

Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020.[5][6][3] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7][8]

In November 2022, GSK plc initiated the process for withdrawal of the United States marketing authorization for belantamab mafodotin following the request of the US FDA.[9] This request was based on the outcome of the DREAMM-3 phase III confirmatory trial,[10] which did not meet the requirements of the US FDA accelerated approval regulations.[11]

Medical uses

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Belantamab mafodotin is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.[2][5][3] However, the phase III DREAMM-3 trial published in 2023, comparing patients with relapsed or refractory multiple myeloma receiving belantamab mafodotin to pomalidimide and dexamethasone did not demonstrate a clinical benefit for belantamab mafodotin. Due to this trial results, the manufacturer is voluntarily withdrawing belantamab mafodotin from the market.[10]

Adverse effects

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The 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.[5][2]

History

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Belantamab mafodotin was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial.[5] 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.[5]

Efficacy was based on overall response rate (ORR) and response duration, as evaluated by an independent review committee using the International Myeloma Working Group uniform response criteria.[5] The ORR was 31% (97.5% CI: 21%, 43%). Seventy-three percent of responders had response durations ≥6 months.[5] These results were observed in participants receiving the recommended dose of 2.5 mg/kg.[5]

The US Food and Drug Administration (FDA) granted the application for belantamab mafodotin priority review, orphan drug, and breakthrough therapy designations.[5]

In 2023, the confirmatory phase III DREAMM-3 trial aimed to compare belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in participants with relapsed or refractory multiple myeloma. Due to the trial results, the manufacturer is voluntarily withdrawing belantamab mafodotin from the market.[10]

Society and culture

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Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020.[5][6][3][8]

Belantamab mafodotin is withdrawn in the United States[12] and the European Union.[3]

Names

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Belantamab mafodotin is the international nonproprietary name (INN).[13]

References

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  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. ^ a b c d e "Blenrep- belantamab injection, powder, lyophilized, for solution". DailyMed. 5 August 2020. Archived from the original on 27 October 2020. Retrieved 11 August 2020.
  3. ^ a b c d e f g h "Blenrep EPAR". European Medicines Agency (EMA). 23 July 2020. Archived from the original on 1 November 2020. Retrieved 24 September 2020.
  4. ^ "Blenrep Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  5. ^ a b c d e f g h i j k l "FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma". U.S. Food and Drug Administration (FDA). 5 August 2020. Archived from the original on 6 August 2020. Retrieved 6 August 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ^ a b c "FDA Approves GSK's Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma" (Press release). GlaxoSmithKline. 6 August 2020. Archived from the original on 6 August 2020. Retrieved 6 August 2020 – via Business Wire.
  7. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021.
  8. ^ a b "Drug Approval Package: Blenrep". U.S. Food and Drug Administration (FDA). 1 August 2020. Archived from the original on 21 January 2021. Retrieved 17 January 2021.
  9. ^ "GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization" (Press release). GSK. 22 November 2022. Archived from the original on 23 November 2022. Retrieved 23 November 2022.
  10. ^ a b c "GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma" (Press release). GSK. 11 July 2022. Archived from the original on 23 November 2022. Retrieved 23 November 2022.
  11. ^ "GlaxoSmithKline Intellectual Property Development Ltd. England; Announcement of the Revocation of the Biologics License for Blenrep". Federal Register. 30 March 2023. Archived from the original on 30 March 2023. Retrieved 15 August 2024.
  12. ^ "FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma". U.S. Food and Drug Administration. 20 March 2023. Archived from the original on 15 August 2024. Retrieved 15 August 2024.
  13. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3): 431–2. hdl:10665/330907. License: CC BY-NC-SA 3.0 IGO.

Further reading

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  • "Belantamab mafodotin". NCI Drug Dictionary. National Cancer Institute.
  • Clinical trial number NCT03525678 for "A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody" at ClinicalTrials.gov
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