Regulatory approval

Published by the European Medicines Agency. Approved

BESPONSA is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease; after a second or greater relapse; and in those with refactory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.

This is written in the approval document.

Citation

Pfizer Europe MA EEIG. Besponsa (inotuzumab ozogamicin) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/besponsa-epar-product-information_en.pdf. Revised May 2026. Accessed August 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	CD22 +	Acute Lymphoblastic Leukemia	Inotuzumab ozogamicin
EMA (1)	CD22 +, not BCR::ABL1	Acute Lymphoblastic Leukemia	Inotuzumab ozogamicin

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-05-06	European Medicines Agency	Indication received approval from the European Commission.