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 . August 18, 2017 – B-cell precursor acute lymphoblastic leukemia is a aggressive and rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell.. The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2). Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.. 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).. European Medicines Agency decision EMA/801040/2017 Page 3/3 Has adopted this decision: Article 1 Changes to the agreed paediatric investigation plan for inotuzumab ozogamicin (Besponsa), powder for. The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals were mainly based on a randomized, open-label study (INO-VATE ALL - NCT01564784) in which Besponsa was tested against chemotherapy..