Belantamab mafodotin
| 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 monoclonal antibody conjugated with a cytotoxic agent for the treatment of relapsed and refractory multiple myeloma.[1][6][7][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][6]
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.[6][7][2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8][9]
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.[10] This request was based on the outcome of the DREAMM-3 phase III confirmatory trial,[11] which did not meet the requirements of the US FDA accelerated approval regulations.[12]
- ^ a b c "Blenrep- belantamab injection, powder, lyophilized, for solution". DailyMed. 5 August 2020. Archived from the original on 27 October 2020. Retrieved 11 August 2020.
- ^ a b c d e "Blenrep EPAR". European Medicines Agency (EMA). 23 July 2020. Archived from the original on 1 November 2020. Retrieved 24 September 2020.
- ^ "Blenrep Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
- ^ Cite error: The named reference
Blenrep EPAR 2was invoked but never defined (see the help page). - ^ Cite error: The named reference
Blenrep PI 2was invoked but never defined (see the help page). - ^ a b c "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. This article incorporates text from this source, which is in the public domain.
- ^ a b "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.