Belantamab mafodotin

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Belantamab mafodotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetB-cell maturation antigen (BCMA) (CD269)
Names
Trade namesBlenrep
Other namesBelantamab mafodotin-blmf, GSK2857916
Clinical data
Drug classAntibody-drug conjugate
Main usesMultiple myeloma[1]
Side effectsKeratopathy, vision problems, nausea, fever, infusion reactions, tiredness[1]
Routes of
use
Intravenous
Typical dose2.5 mg/kg[1]
External links
AHFS/Drugs.comMonograph
US NLMBelantamab mafodotin
Legal
License data
Legal status
Chemical and physical data
FormulaC6484H10008N1728O2030S44. (C49H66N6O11)4

Belantamab mafodotin, sold under the brand name Blenrep, is a medication used to treat multiple myeloma.[1][2] It is used when other treatments are no longer effective.[1] It is given by injection into a vein.[1]

Common side effects include keratopathy, vision problems, nausea, fever, infusion reactions, and tiredness.[1] Other side effects may include low platelets.[1] Use in pregnancy may harm the baby.[1] It is a monoclonal antibody joined to the cytotoxic agent monomethyl auristatin F (MMAF).[2][3] The antibody binds to B-cell maturation antigen (BCMA) found on myeloma cells.[2]

Belantamab mafodotin was approved for medical use in the United States and Europe in 2020.[1][2] In the United States it costs about 8,800 USD per 100 mg vial as of 2022.[4] In the United Kingdom this amount costs the NHS about £5700.[5]

Medical uses

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.[1][6][2]

Dosage

It is give at a dose of 2.5 mg/kg once every 3 weeks.[1]

Side effects

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.[6][1]

Because of the risks of ocular toxicity, belantamab mafodotin is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the BLENREP REMS.[6]

History

Belantamab mafodotin was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial.[6] 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.[6]

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.[6] The ORR was 31% (97.5% CI: 21%, 43%). Seventy-three percent of responders had response durations ≥6 months.[6] These results were observed in participants receiving the recommended dose of 2.5 mg/kg.[6]

The U.S. Food and Drug Administration (FDA) granted the application for belantamab mafodotin priority review, orphan drug designation, and breakthrough therapy designation.[6]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7][8]

Society and culture

Legal status

Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020.[6][2][8]

Names

Belantamab mafodotin is the international nonproprietary name (INN).[9]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 "Blenrep- belantamab injection, powder, lyophilized, for solution". DailyMed. 5 August 2020. Retrieved 11 August 2020.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "Blenrep EPAR". European Medicines Agency (EMA). 23 July 2020. Retrieved 24 September 2020.
  3. "Belantamab Mafodotin-blmf Monograph for Professionals". Drugs.com. Retrieved 8 January 2022.
  4. "Blenrep Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 8 January 2022.
  5. "Belantamab mafodotin". SPS - Specialist Pharmacy Service. 17 September 2019. Retrieved 8 January 2022.
  6. 6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 "FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma". U.S. Food and Drug Administration (FDA). 5 August 2020. Retrieved 6 August 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  7. "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021.
  8. 8.0 8.1 "Drug Approval Package: Blenrep". U.S. Food and Drug Administration (FDA). 1 August 2020. Retrieved 17 January 2021.
  9. 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.

External links

Identifiers:
  • "Belantamab mafodotin". Drug Information Portal. U.S. National Library of Medicine.
  • "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