inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland. Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (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 orphan medicinal product on 7 June 2013. The applicant for . Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved 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. ‘BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL)’. Following the CHMP positive opinion on this marketing authorisation, the Committee for Orphan Medicinal. Moda Health Plan, Inc. Medical Necessity Criteria Page 3/3 3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) inotuzumab ozogamicin.. Page 3 | BESPONSA (inotuzumab ozogamicin) Prior Auth Criteria Proprietary Information. Restricted Access – Do not disseminate or copy without approval..