Therapeutic Response

CD22 + status confers therapeutic sensitivity to Inotuzumab ozogamicin in patients with Acute Lymphoid Leukemia.

Statements

Source and description
Besponsa (inotuzumab ozogamicin) [product information]. EMA.

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).
Besponsa (inotuzumab ozogamicin) [package insert]. FDA.

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).
Inotuzumab Ozogamicin Monotherapy. NCCP National SACT Regimen. HSE.

The Republic of Ireland's Health Service Executive (HSE) has approved inotuzumab ozogamicin for reimbursement as a monotherapy treatment option for the treatment of adult patients with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL). The indication further states that 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).