European Commission approves Besponsa (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL)- Pfizer

Pfizer Inc. has announced that the European Commission has approved Besponsa (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. Adults with Ph+ relapsed or refractory CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor (TKI). With this approval, Besponsa becomes the first and only antibody drug conjugate (ADC) available for patients with this type of leukaemia in the European Union (EU).

ALL is an aggressive type of leukaemia that can be fatal within a matter of months if left untreated. The goal of treatment in relapsed or refractory (resistant) ALL is to achieve complete remission without excessive toxicity so patients may proceed to additional therapeutic intervention. Stem cell transplant is the most recognised option to prolong patient survival, maintenance therapy or other therapy. In adult patients with relapsed or refractory ALL, median overall survival is just 3–6 months. The current standard of care is intensive chemotherapy, which is effective in less than 50% of relapsed or refractory patients and associated with poor long-term survival, high toxicities, lengthy inpatient stays and continuous infusions.