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.
BESPONSA (inotuzumab oxogamicin) is recommended as an option for treating relapsed or refractory CD22-positive B-call precursor acute lymphoblastic leukaemia in adults. People with relapsed or refractory Philadelphia chromosome positive disease should have had at least 1 tyrosine kinase inhibitor (TKI).
Advice: following a full submission assessed under the ultra-orphan and end of life medicine process:
Inotuzumab ozogamicin (BESPONSA) is accepted for restricted use within NHS Scotland.
Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive relapsed or refractory B cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor.
SMC restriction: in patients for whom the intent is to proceed to stem cell transplantation.
A phase III open label randomised controlled study demonstrated improvements in remission rates and overall survival for the patient population under review when treated with inotuzumab ozogamicin compared with standard chemotherapy.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of inotuzumab ozogamicin. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting
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
Hear Professor David Marks discuss the INO-VATE study including MRD negativity, long term survival and reducing risks of veno-occlusive disease
NICE, National Institute for Health and Care Excellence; SMC, Scottish Medicines Consortium
▼ 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.
Download the Fast Facts Guide holding the key information for BESPONSA including mode of action, INO-VATE study design, INO-VATE results; efficacy and safety profile. Summary of Product Characteristics (SmPC) should be consulted for full guidance.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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PP-PFE-GBR-3863. November 2021