Regulatory approval

Published by the Health Canada.

Health Canada approved inotuzumab ozogamicin as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

This is written in the approval document as:

BESPONSA (inotuzumab ozogamicin for injection) is indicated for monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

Citation

Pfizer Canada ULC. Besponsa (inotuzumab ozogamicin) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00077730.PDF. Revised November 2024. Accessed June 2025.

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