Mosunetuzumab Explained

Mosunetuzumab, sold under the brand name Lunsumio, is a monoclonal antibody used for the treatment of follicular lymphoma. It bispecifically binds CD20 and CD3 to engage T-cells. It was developed by Genentech.^[4]

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

Mosunetuzumab was approved for medical use in the European Union in June 2022, and in the United States in December 2022.^[5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^{[6] [7]}

Medical uses

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

Contraindications

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

History

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

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

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. The applicant for this medicinal product is Roche Registration GmbH.^[8] Mosunetuzumab was approved for medical use in the European Union in June 2022.^[9]

Names

Mosunetuzumab is the international nonproprietary name (INN).^[10]

Further reading

• Budde LE, Assouline S, Sehn LH, Schuster SJ, Yoon SS, Yoon DH, Matasar MJ, Bosch F, Kim WS, Nastoupil LJ, Flinn IW, Shadman M, Diefenbach C, O'Hear C, Huang H, Kwan A, Li CC, Piccione EC, Wei MC, Yin S, Bartlett NL . 6 . 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 . 34914545 . 8824395 . 10.1200/JCO.21.00931 . doi . free .

Notes and References

1. Web site: Lunsumio- mosunetuzumab concentrate . DailyMed . 22 December 2022 . 21 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121044850/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ef0cf38-101c-4681-98fe-c05dc9ead443 . live .
2. Web site: FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma . U.S. Food and Drug Administration (FDA) . 22 December 2022 . 3 January 2023 . 4 January 2023 . https://web.archive.org/web/20230104033950/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mosunetuzumab-axgb-relapsed-or-refractory-follicular-lymphoma . live .
3. Web site: Lunsumio EPAR . European Medicines Agency (EMA) . 13 April 2022 . 3 January 2023 . 4 January 2023 . https://web.archive.org/web/20230104035609/https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
4. Carvalho T . FDA approves Genentech's bispecific antibody for lymphoma . Nature Medicine . 29 . 3 . 507–508 . March 2023 . 36697979 . 10.1038/d41591-023-00010-0 . 6 February 2023 . live . 256273270 . https://web.archive.org/web/20230206145448/https://www.nature.com/articles/d41591-023-00010-0 . 6 February 2023 .
5. Web site: Lunsumio: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 3 January 2023 . 4 January 2023 . https://web.archive.org/web/20230104034330/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761263 . live .
6. Web site: Advancing Health Through Innovation: New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . 10 January 2023 . 22 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 . live .
7. New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 14 January 2024 . https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download . 14 January 2024 . live .
8. Web site: Lunsumio: Pending EC decision . European Medicines Agency (EMA) . 22 April 2022 . 22 April 2022 . 22 April 2022 . https://web.archive.org/web/20220422155616/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/lunsumio . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
9. Web site: Lunsumio Product information . Union Register of medicinal products . 3 March 2023.
10. ((World Health Organization)) . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 . WHO Drug Information . 32 . 1 . 2018 . 10665/330941 . free . World Health Organization .