Mosunetuzumab

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Mosunetuzumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD20, CD3 (bispecific)
Names
Trade namesLunsumio
Other namesBTCT4465A, RG7828, mosunetuzumab-axgb
Clinical data
Drug classAntineoplastic
Main usesFollicular lymphoma[1]
Side effectsCytokine release syndrome, fever, headache, infections[2]
Routes of
use		Gradual injection into a vein[1]
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status
Chemical and physical data
FormulaC6515H10031N1725O2025S43
Molar mass146301.54 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, fever, and headache.[2] Other side effects may include immune effector cell-associated neurotoxicity syndrome (ICANS) and infections.[1] Common laboratory abnormalities include decreased low neutrophils, low phosphate, high glucose, low lymphocytes, increased uric acid, low white blood cells, low hemoglobin, and low platelets.[2][1] Use in pregnancy may harm the baby.[1] 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.[2][1] It costs about 180,000 USD for the course of treatment in the United States as of 2023.[4]

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][2]

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] The FDA considers it to be a first-in-class medication.[5]

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.[6] The applicant for this medicinal product is Roche Registration GmbH.[6] Mosunetuzumab was approved for medical use in the European Union in June 2022.[2]

Names

Mosunetuzumab is the international nonproprietary name (INN).[7]

References

  1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 "Lunsumio- mosunetuzumab concentrate". DailyMed. 22 December 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  2. ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "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.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ "U.S. FDA approves Roche's lymphoma therapy". Reuters. 23 December 2022. Archived from the original on 4 January 2023. Retrieved 9 April 2023.
  5. ↑ "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. Public Domain This article incorporates text from this source, which is in the public domain.
  6. ↑ 6.0 6.1 "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.
  7. ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.

External links

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Identifiers:
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