Therapeutic Response

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

Statements

Source and description
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).
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) [product information]. EMA.

The European Medicines Agency (EMA) has authorized inotuzumab ozogamicin as a monotherapy for the treatment of pediatric patients aged 1 year and older with CD22-positive B cell precursor acute lymphoblastic leukemia (ALL): in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease; after a second or greater relapse; and in those with refactory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.