Global InformationTalquetamab information
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | GPRC5D, CD3 |
| Clinical data | |
| Trade names | Talvey |
| Other names | Talquetamab-tgvs |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a623047 |
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| Routes of administration | Subcutaneous |
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Talquetamab, sold under the brand name Talvey, is a humanized monoclonal antibody used for the treatment of multiple myeloma.[1][4] It is a bispecific GPRC5D-directed CD3 T-cell engager.[1] Talquetamab is a bispecific antibody against two targets: human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen with potential antineoplastic activity.[5] Talquetamab binds both targets, drawing the T cells close to the tumor cells, causing a cytotoxic T-lymphocyte response.[5] It is being developed by Janssen Pharmaceuticals.[6]
The most common adverse reactions include cytokine release syndrome, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.[7]
Talquetamab was approved for medical use in both the United States[1][7][8] and the European Union[3] in August 2023. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]
- ^ a b c d e "Talvey- talquetamab injection". DailyMed. U.S. National Library of Medicine. 18 August 2023. Archived from the original on 24 August 2023. Retrieved 23 August 2023.
- ^ "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.
- ^ a b Cite error: The named reference
EU Talvey PIwas invoked but never defined (see the help page). - ^ a b "Talvey EPAR". European Medicines Agency. 21 September 2023. Retrieved 6 October 2023.
- ^ a b "Talquetamab". NCI Drug Dictionary. National Cancer Institute. Archived from the original on 11 August 2023. Retrieved 30 January 2023.
- ^ Chari A, Minnema MC, Berdeja JG, Oriol A, van de Donk NW, Rodríguez-Otero P, et al. (December 2022). "Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma". The New England Journal of Medicine. 387 (24): 2232–2244. doi:10.1056/NEJMoa2204591. PMID 36507686. S2CID 254560960.
- ^ a b "FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 9 August 2023. Archived from the original on 11 August 2023. Retrieved 10 August 2023.
This article incorporates text from this source, which is in the public domain.
- ^ Theoret MR (2023). "Talvey (talquetamab-tgvs) injection" (PDF). Approval Letter. U.S. Food and Drug Administration. Archived from the original (PDF) on 11 August 2023. This article incorporates text from this source, which is in the public domain.
- ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
