BESPONSA is a CD22-directed antibody-drug conjugate (ADC) indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. Besponsa . inotuzumab ozogamicin . On 21 April 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a . marketing authorisation for the medicinal product Besponsa, intended for the treatment of adults with acu te lymphoblastic leukaemia . Besponsa was designated as an. Besponsa (inotuzumab) is an antibody drug conjugate which is comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on around 90 percent of B-cell malignancies, linked to a cytotoxic agent.. Mylotarg is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults. Relapsed or Refractory CD33-positive AML. Mylotarg is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older. Mylotarg Dosage and Administration. source: uspi for clolar, blincyto, marqibo, besponsa Regulatory History and Considerations Key regulatory milestones in the development of KYMRIAH are summarized below.. .