Inotuzumab Ozogamicin: First Pediatric Approval.
Paediatr Drugs
; 26(4): 459-467, 2024 Jul.
Article
in En
| MEDLINE
| ID: mdl-38780741
ABSTRACT
Inotuzumab ozogamicin (BESPONSA™) is a CD22-targeted monoclonal antibody drug conjugate (ADC) developed by Pfizer for the treatment of CD22-postive B-cell precursor acute lymphoblastic leukaemia (ALL). Inotuzumab ozogamicin comprises a humanized IgG4 anti-CD22 monoclonal antibody covalently linked to the potent DNA-binding cytotoxic agent N-acetyl-gamma-calicheamicin dimethylhydrazide (CalichDMH) via a linker. Inotuzumab ozogamicin binds to CD22-expressing tumour cells, facilitating the delivery of conjugated CalichDMH, which after intracellular activation induces double strand DNA breaks, ultimately leading to cell cycle arrest and apoptotic cell death. Inotuzumab ozogamicin is approved in the USA, Europe and several countries worldwide for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in adults. On 6 March 2024, inotuzumab ozogamicin received its first pediatric approval in the USA for this indication in patients aged ≥ 1 years. Inotuzumab ozogamicin has since been approved in Japan in March 2024 for the same indication in pediatric patients. This article summarizes the milestones in the development of inotuzumab ozogamicin leading to this first approval for the treatment of relapsed or refractory CD22-positive B-cell precursor ALL in pediatric patients.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Drug Approval
/
Inotuzumab Ozogamicin
Limits:
Child
/
Humans
Language:
En
Journal:
Paediatr Drugs
/
Paediatr. drugs (Online)
/
Paediatric drugs (Online)
Journal subject:
PEDIATRIA
/
TERAPIA POR MEDICAMENTOS
Year:
2024
Document type:
Article
Affiliation country:
Nueva Zelanda
Country of publication:
Suiza