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EfficacyEfficacyKey HighlightsEfficacyHospitalisation DataSafetySafetySafetyAdverse Event Management: VOD/SOSKey PrecautionsDosingDosingDosingAdministrationSupport and ResourcesSupport and ResourcesSupport and ResourcesGuidelinesFast FactsPharmacy GuidePatient SupportDevelopments in Leukaemia Care videoKey data from the INO-VATE study videoManagement of Refractory/Relapsed ALL videoMRD PubExplainer videoINO-VATE PubExplainer videoVideosMaterials

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.

Key HighlightsCompared with standard chemotherapy, BESPONSA offers in R/R ALL:With BESPONSA, bridge more of your R/R ALL patients to curative therapy than with standard chemotherapy1

​​​​​​​*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.​​​​​​​

Developments in Leukaemia Care

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

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Key data from the INO-VATE study 

Here Dr. Anna Castleton discuss the key data for BESPONSA vs standard care from the INO-VATE study

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 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.

ReferencesKantarjian HM, et al. N Engl J Med 2016;375:740–753BESPONSA Summary of Product Characteristics for Great Britain click here. BESPONSA Summary of Product Characteristics for Northern Ireland click here.Marks DI, et al. Cancer Med 2019; 5959-5968Kantarjian HM, et al. Cancer 2018; 124; 2151-2160European Medicines Agency. EPAR, inotuzumab (EMA/289046/2017). Available at: https://www.ema.europa.eu/en/documents/assessment-report/besponsa-epar-public-assessment-report_en.pdf [accessed August 2021]
PP-INO-GBR-0496. August 2021
Quick links Access Support and Resources to read the guidelines, watch videos with leading specialists.  Access  here Loading

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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