Adverse Reaction Reporting for Naxitamab in Chinese Expanded Access Treatment for Relapsed/Refractory High-Risk Neuroblastoma at the Children's Hospital of Fudan University.

ABSTRACT:

Background

The humanized anti-disialoganglioside-2 monoclonal antibody naxitamab was approved in the USA in 2020 for the treatment of patients with relapsed/refractory high-risk neuroblastoma, limited to the bone or bone marrow, in combination with granulocyte-macrophage colony-stimulating factor. Treatment with naxitamab under expanded access was initiated by physicians from the Children's Hospital of Fudan University, Shanghai, China, in August 2021.

Objective

We reviewed all suspected adverse reactions (ARs) reported to the Y-mAbs Argus Global Pharmacovigilance Safety Database for patients treated with naxitamab under expanded access in China from 1 August 2021 to 31 July 2022.

Methods

We assessed patient demographics and the safety profile of naxitamab over multip

SUBMITTER: Qian X 

PROVIDER: S-EPMC11829859 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature