Release. The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment,. On 7 June 2013, orphan designation (EU/3/13/1127) was granted by the European Commission to Pfizer Limited, United Kingdom, for inotuzumab ozogamicin for the treatment of B-cell acute lymphoblastic leukaemia. Inotuzumab ozogamicin has been authorised in the EU as Besponsa since 29 June 2017.. Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare’, and Besponsa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 7 June 2013.. The National Institute of Healthcare and Excellence (NICE) is set to reject Pfizer’s orphan drug for leukaemia Besponsa (inotuzumab ozogamicin). Pfizer issued a robust defence of its product, saying the UK cost-effectiveness watchdog’s final appraisal determination had ‘inappropriately’ assessed the drug’s value.. . .