Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that CD22 + status confers therapeutic sensitivity to Inotuzumab ozogamicin in patients with Acute Lymphoid Leukemia.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
BESPONSA is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor 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.