Posted by Michael Wonder on 03 Jul 2017
Besponsa approved in the EU for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
30 June 2017 - Pfizer today 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.
This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
Adults with Ph+ relapsed or refractory CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor. With this approval, Besponsa becomes the first and only antibody drug conjugate available for patients with this type of leukaemia in the European Union.
