Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized Besponsa (inotuzumab ozogamicin) as a monotherapy for the treatment of adult patients with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL). Adult patients with Philidelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor (TKI).

This is written in the approval document as:

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).

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.

Therapeutic response

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

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