Mosunetuzumab

Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma.^[2][3][5] It bispecifically binds CD20 and CD3 to engage T-cells.^[2][3] It was developed by Genentech.^[6]

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	US DailyMed: Mosunetuzumab
Drug class	Antineoplastic
ATC code	L01FX25 (WHO)
Legal status
Legal status	US: WARNING[1]Rx-only[2][3] EU: Rx-only[4]
Identifiers
CAS Number	1905409-39-3
DrugBank	DB15434
UNII	LDJ89SS0YG
KEGG	D11463
Chemical and physical data
Formula	C6515H10031N1725O2025S43
Molar mass	146301.54 g·mol−1

The most common adverse reactions (≥20%) include cytokine release syndrome, fatigue, rash, pyrexia, and headache.^[3][4] 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.^[3][4]

Mosunetuzumab was approved for medical use in the European Union in June 2022,^[4] and in the United States in December 2022.^[3][7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[8][9]

Medical uses

Mosunetuzumab is indicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.^[3][4]

Contraindications

The prescribing information for mosunetuzumab in the US has a boxed warning for serious or life-threatening cytokine release syndrome.^[3]

History

Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study.^[3] 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.^[3]

The US Food and Drug Administration (FDA) granted the application for mosunetuzumab priority review, breakthrough therapy, and orphan drug designations.^[3]

Society and culture

Legal status

In 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.^[4][10]

Names

Mosunetuzumab is the international nonproprietary name (INN).^[11]

References

1. "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.
2. "Lunsumio- mosunetuzumab concentrate". DailyMed. 22 December 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
3. "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.
4. "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.
5. "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.
6. 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.
7. "Lunsumio: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 4 January 2023. Retrieved 3 January 2023.
8. "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.
9. 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.
10. "Lunsumio Product information". Union Register of medicinal products. Retrieved 3 March 2023.
11. 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.

External links

• 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