Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to inotuzumab ozogamicin for the treatment of adult and pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

This is written in the approval document as:

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.

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.

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