Chemistry:Belantamab mafodotin
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | B-cell maturation antigen (BCMA) (CD269) |
| Clinical data | |
| Trade names | Blenrep |
| Other names | belantamab mafodotin-blmf, GSK2857916 |
| AHFS/Drugs.com | Monograph |
| License data | |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6484H10008N1728O2030S44. (C49H66N6O11)4 |
Belantamab mafodotin, sold under the brand name Blenrep, is a medication for the treatment of relapsed and refractory multiple myeloma.[1][4][5][2]
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.[1][4]
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).[2] The antibody-drug conjugate binds to BCMA on myeloma cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.[2]
Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020.[4][5][2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6][7]
On November 22, 2022, GSK plc announced it initiated the process for withdrawal of the United States marketing authorization for belantamab mafodotin following the request of the U.S. FDA.[8] This request was based on the outcome of the DREAMM-3 phase III confirmatory trial, [9] which did not meet the requirements of the U.S. FDA Accelerated Approval regulations.
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][4][2]
Adverse 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.[4][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.[4]
History
Belantamab mafodotin was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial.[4] 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.[4]
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.[4] The ORR was 31% (97.5% CI: 21%, 43%). Seventy-three percent of responders had response durations ≥6 months.[4] These results were observed in participants receiving the recommended dose of 2.5 mg/kg.[4]
The U.S. Food and Drug Administration (FDA) granted the application for belantamab mafodotin priority review, orphan drug designation, and breakthrough therapy designation.[4]
Society and culture
Legal status
Belantamab mafodotin was approved for medical use in the United States and in the European Union in August 2020.[4][5][2][7]
Names
Belantamab mafodotin is the international nonproprietary name (INN).[10]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 "Blenrep- belantamab injection, powder, lyophilized, for solution". 5 August 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16a160a4-3ec0-4ddf-99ce-05912dd3382d.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "Blenrep EPAR". 23 July 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep.
- ↑ "Blenrep Product information". https://ec.europa.eu/health/documents/community-register/html/h1474.htm.
- ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 "FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma". 5 August 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma.
This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 5.2 "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. Retrieved 6 August 2020 – via Business Wire.
- ↑ "New Drug Therapy Approvals 2020". 31 December 2020. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020.
- ↑ 7.0 7.1 "Drug Approval Package: Blenrep". 1 August 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761158Orig1s000TOC.cfm.
- ↑ "GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorization". GSK. 22 November 2022. https://us.gsk.com/en-us/media/press-releases/gsk-provides-an-update-on-blenrep-belantamab-mafodotin-blmf-us-marketing-authorization/.
- ↑ "GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma". GSK. 11 July 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-dreamm-3-phase-iii-trial-for-blenrep/.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information 32 (3): 431–2. 2018. License: CC BY-NC-SA 3.0 IGO.
Further reading
- "Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study". Blood Cancer J 9 (4): 37. March 2019. doi:10.1038/s41408-019-0196-6. PMID 30894515.
- "Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study". Lancet Oncol. 21 (2): 207–221. February 2020. doi:10.1016/S1470-2045(19)30788-0. PMID 31859245.
External links
- "Belantamab mafodotin". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/belantamab%20mafodotin.
- "Belantamab mafodotin". NCI Drug Dictionary. National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-drug.
- 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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