Regulatory approval

Published by the Food and Drug Administration. Approved

BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.

This is written in the approval document.

Citation

Wyeth Pharmaceuticals LLC. Besponsa (inotuzumab ozogamicin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761040s003lbl.pdf. Revised March 2024. Accessed October 30, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	CD22 +	Acute Lymphoblastic Leukemia	Inotuzumab ozogamicin

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-03-06	Food and Drug Administration	Indication received traditional approval.