Mosunetuzumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CD20, CD3 (bispecific) |
| Names | |
| Trade names | Lunsumio |
| Other names | BTCT4465A, RG7828, mosunetuzumab-axgb |
| Clinical data | |
| Drug class | Antineoplastic |
| Main uses | Follicular lymphoma[1] |
| Legal | |
| License data | |
| Legal status | |
| Chemical and physical data | |
| Formula | C6515H10031N1725O2025S43 |
| Molar mass | 146301.54 g·mol−1 |
Mosunetuzumab, sold under the brand name Lunsumio, is a medication used to treat follicular lymphoma.[1] Specifically it is used after other medications have failed.[1] It is given by gradual injection into a vein.[1]
Common side effects (≥20%) include cytokine release syndrome, tiredness, rash, fever, and headache.[2][3] Common laboratory abnormalities 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] It is a monoclonal antibody specifically a bispecific CD20-directed CD3 T-cell engager.[1][2]
Mosunetuzumab was approved for medical use in Europe and the United States in 2022.[3][1]
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] The FDA considers it to be a first-in-class medication.[4]
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.[5] The applicant for this medicinal product is Roche Registration GmbH.[5] Mosunetuzumab was approved for medical use in the European Union in June 2022.[3]
Names
Mosunetuzumab is the international nonproprietary name (INN).[6]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "Lunsumio- mosunetuzumab concentrate". DailyMed. 22 December 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "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.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 "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.
- ↑ "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.
- ↑ 5.0 5.1 "Lunsumio: Pending EC decision". European Medicines Agency (EMA). 22 April 2022. Archived from the original on 22 April 2022. Retrieved 22 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.
Further reading
- Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, et al. (February 2022). "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. doi:10.1200/JCO.21.00931. PMC 8824395. PMID 34914545.
{{cite journal}}: CS1 maint: PMC embargo expired (link)
External links
| External sites: | |
|---|---|
| Identifiers: |
|
- 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
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