Besponsa (inotuzumab ozogamicin) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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 February 2024. Accessed March 6, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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).	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD22 +	Acute Lymphoid Leukemia	Inotuzumab ozogamicin
Sensitivity (+)	BCR::ABL1, CD22 +	Acute Lymphoid Leukemia	Inotuzumab ozogamicin