| 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 nameLunsumio, is amonoclonal antibody used for the treatment offollicular lymphoma.[2][3][5] It bispecifically binds CD20 and CD3 to engage T-cells.[2][3] It was developed byGenentech.[6]
The most common adverse reactions (≥20%) includecytokine 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 USFood and Drug Administration (FDA) considers it to be afirst-in-class medication.[8][9]
Mosunetuzumab isindicated for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[3][4]
The prescribing information for mosunetuzumab in the US has aboxed warning for serious or life-threatening cytokine release syndrome.[3]
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 USFood and Drug Administration (FDA) granted the application for mosunetuzumabpriority review,breakthrough therapy, andorphan drug designations.[3]
In April 2022, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean 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]
Mosunetuzumab is theinternational nonproprietary name (INN).[11]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
