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 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).
This statement is based on a regulatory approval from the Health Service Executive:
Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). 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).