New hard-to-treat leukemia drug Besponsa approved in the Europe

Following a positive recommendation in April from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved US pharma giant Pfizer’s (NYSE: PFE) Besponsa(inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (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 leukemia in the European Union (EU).

In 2013, inotuzumab ozogamicin was effectively dumped by Pfizer after a failed Phase III study in non-Hodgkin lymphoma (NHL) but was later brought back to life.