Mosunetuzumab
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Humanized |
| Target | CD20, CD3 |
| Clinical data | |
| Trade names | Lunsumio |
| Other names | BTCT4465A, RG7828, mosunetuzumab-axgb |
| AHFS/Drugs.com | Monograph |
| License data | |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6515H10031N1725O2025S43 |
| Molar mass | 146301.54 g·mol−1 |
Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma.[1][2][4] It bispecifically binds CD20 and CD3 to engage T-cells.[1][2] It was developed by Genentech.[5]
The most common adverse reactions (≥20%) include cytokine release syndrome, fatigue, rash, pyrexia, and headache.[2][3] The most common grade 3 to 4 laboratory abnormalities (≥10%) include decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets.[2][3]
Mosunetuzumab was approved for medical use in the European Union in June 2022,[3] and in the United States in December 2022.[2][6] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7][8]
- ^ a b c "Lunsumio- mosunetuzumab concentrate". DailyMed. 22 December 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
- ^ a b c d e f "FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma". U.S. Food and Drug Administration (FDA). 22 December 2022. Archived from the original on 4 January 2023. Retrieved 3 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ a b c d "Lunsumio EPAR". European Medicines Agency (EMA). 13 April 2022. Archived from the original on 4 January 2023. Retrieved 3 January 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Cite error: The named reference
Lunsumio: Pending EC decisionwas invoked but never defined (see the help page). - ^ Carvalho T (March 2023). "FDA approves Genentech's bispecific antibody for lymphoma". Nature Medicine. 29 (3): 507–508. doi:10.1038/d41591-023-00010-0. PMID 36697979. S2CID 256273270. Archived from the original on 6 February 2023. Retrieved 6 February 2023.
- ^ "Lunsumio: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 4 January 2023. Retrieved 3 January 2023.
- ^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.