Besponsa EMA/269417/2017 Page 2/3 Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow , the only curative treatment.. The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%).. Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. EMA/CHMP/245560/2017 . Committee for Medicinal Products for Human Use (CHMP) Summary of opinion. 1 (initial authorisation) 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 . Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC). Besponsa is specifically indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.. “The approval of BESPONSA (inotuzumab ozogamicin) provides a much needed treatment option for physicians and patients alike, that may help improve outcomes for some of the most vulnerable .