Chemistry: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]
Medical uses
Mosunetuzumab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[2][3]
Contraindications
The prescribing information for mosunetuzumab in the US has a boxed warning for serious or life-threatening cytokine release syndrome.[2]
History
Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study.[2] The efficacy population consisted of 90 patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent.[2]
The US Food and Drug Administration (FDA) granted the application for mosunetuzumab priority review, breakthrough therapy, and orphan drug designations.[2]
Society and culture
Legal status
On 22 April 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for mosunetuzumab under the brand name Lunsumio, intended for the treatment of relapsed or refractory follicular lymphoma.[4] The applicant for this medicinal product is Roche Registration GmbH.[4] Mosunetuzumab was approved for medical use in the European Union in June 2022.[3][9]
Names
Mosunetuzumab is the international nonproprietary name (INN).[10]
References
- ↑ 1.0 1.1 1.2 "Lunsumio- mosunetuzumab concentrate". 22 December 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ef0cf38-101c-4681-98fe-c05dc9ead443.
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma". U.S. Food and Drug Administration (FDA). 22 December 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mosunetuzumab-axgb-relapsed-or-refractory-follicular-lymphoma.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 "Lunsumio EPAR". 13 April 2022. https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 4.0 4.1 4.2 "Lunsumio: Pending EC decision". 22 April 2022. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/lunsumio. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "FDA approves Genentech's bispecific antibody for lymphoma". Nature Medicine 29 (3): 507–508. March 2023. doi:10.1038/d41591-023-00010-0. PMID 36697979. https://www.nature.com/articles/d41591-023-00010-0. Retrieved 6 February 2023.
- ↑ "Lunsumio: FDA-Approved Drugs". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761263.
- ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". 10 January 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022. This article incorporates text from this source, which is in the public domain.
- ↑ (PDF) New Drug Therapy Approvals 2022 (Report). January 2024. https://www.fda.gov/media/164429/download. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.
- ↑ "Lunsumio Product information". https://ec.europa.eu/health/documents/community-register/html/h1649.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018.
Further reading
- "Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study". Journal of Clinical Oncology 40 (5): 481–491. February 2022. doi:10.1200/JCO.21.00931. PMID 34914545.
External links
- "Mosunetuzumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/mosunetuzumab.
- Clinical trial number NCT02500407 for "A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)" at ClinicalTrials.gov
 |  |
