Pfizer releases a statement on the change in a NICE decision which sees BESPONSA®▼ (inotuzumab ozogamicin) recommended for relapsed or refractory acute lymphoblastic leukaemia (ALL) patients.
ALL is a rare and aggressive type of leukaemia that can be fatal within a matter of months if left untreated. Currently, there are few treatment options that can help patients achieve complete remission, and patients often have a poor prognosis, with a median overall survival of just three to six months.
The NICE approval is based on data from the phase 3 clinical trial, INO-VATE 1022, which showed that inotuzumab ozogamicin helped more than 80% of patients achieve rapid, complete remission. In addition, over three times as many patients were able to receive a stem cell transplant directly after treatment with inotuzumab ozogamicin than with standard chemotherapy.
Inotuzumab ozogamicin is an antibody drug conjugate comprised of a monoclonal antibody targeting CD22, a cell surface antigen expressed on cancer cells in almost all B-cell ALL patients, linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is internalised into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.
Dr Craig Eagle, Head of Oncology, Pfizer UK said: “We welcome NICE’s decision and are pleased that leukaemia patients across the country will now have routine access to this potentially transformative treatment option. We are particularly thankful to the clinical and patient group community who also worked tirelessly throughout this process to ensure patients who can benefit from inotuzumab ozogamicin have access to it.”
Professor David Marks, Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, and Transplant Coordinator of the National Cancer Research Institute (NCRI) Adult ALL Group said: “Today’s announcement is good news for patients across the country who have been diagnosed with this type of relapsed or refractory acute lymphoblastic leukaemia. Inotuzumab ozogamicin can offer patients a life-line, giving them the chance to go into complete remission and become eligible for a potentially curative allogeneic stem-cell transplant. The news that this drug is now routinely available through the NHS will therefore be a welcome relief for eligible patients and their families.”
Zack Pemberton-Whiteley, Campaigns and Advocacy Director, Leukaemia Care, said: “Leukaemia Care works to ensure that patients with blood cancer are given the highest possible standard of care. We are therefore delighted that after successfully appealing NICE’s previous recommendation, people in England and Wales with this particular form of ALL will have access to inotuzumab ozogamicin, providing them and their families with an important additional treatment option.”