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 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 statement is based on a regulatory approval from the Food and Drug Administration:
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.