Inotuzumab Ozogamicin Approved in the EU for Adult Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

Today the European Commission approved inotuzumab ozogamicin as monotherapy for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the US Food and Drug Administration is August 2017. Listen to Dr Elias Jabbour of the MD Anderson Cancer Center provide expert commentary and insights on the clinical trial data leading to the EU approval of inotuzumab ozogamicin.


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