Regulatory approval

Published by the European Medicines Agency. Approved

BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

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
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-06-28	European Medicines Agency	Indication received approval from the European Commission.