This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
The content of this website has been produced in line with the BESPONSA®▼ (inotuzumab ozogamicin) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BESPONSA▼ Prescribing Information for Great Britain click here. BESPONSA▼ Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
*Data for CR/CRi from the prespecified primary analysis of n = 109 in either arm. Between-group differences were 51.4% (97.5% CI, 38.4–64.3) for CR/CRi and 50.3% (97.5% CI, 29.9–70.6) for CR/CRi (MRD negative); p < 0.001.
The two-sided p values for between-group differences were determined by means of the chi-square test or Fisher’s exact test (if any cell count was < 5).
†Data for transplant and OS analysis from the ITT population: 2-year OS 22.8% vs 10.0% with standard chemotherapy.2 ‡HR, 0.751 (97.5% CI, 0.588–0.959; 2-sided p-value = 0.0210).
Additional OS data are available in the current BESPONSA SmPC.2 A modified analysis of median OS data, carried out by the European Medicines Agency, demonstrated a significantly longer median OS with BESPONSA compared with standard chemotherapy.5
CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete haematological recovery of peripheral blood counts; HR, hazard ratio; HSCT, haematopoietic stem cell transplantation; ITT, intention-to-treat; MRD, minimal residual disease; OS, overall survival; QoL, quality of life; R/R ALL, relapsed/refractory acute lymphoblastic leukaemia; SC, standard chemotherapy; SmPC, Summary of Product Characteristics.
Watch Professor David Marks discuss targeted therapies and the INO-VATE study, including 3 year follow up and impact of allogeneic bone marrow transplantation on survival
Here Dr. Anna Castleton discuss the key data for BESPONSA vs standard care from the INO-VATE study
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-PFE-GBR-3863. November 2021