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BESPONSA® granted NICE reassessment: Pfizer responds

Amy Schofield 04 January 2018

Pfizer has commented on the successful appeal hearing which saw BESPONSA® q (inotuzumab ozogamicin) granted reassessment by NICE as a treatment for adults with relapsed or refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

On Thursday 28th December 2017, Pfizer announced that its appeal had been upheld against the National Institute for Health and Care Excellence’s (NICE) decision not to recommend BESPONSA® (inotuzumab ozogamicin) as a treatment for adults with the disease.
 
Craig Eagle, Head of Oncology, Pfizer UK, said: “NICE’s decision to uphold the appeal and re-assess the evidence for inotuzumab ozogamicin is good news for some of the most vulnerable leukaemia patients in the UK. Pfizer is committed to ongoing collaboration with NICE to ensure that eligible patients are granted access to inotuzumab ozogamicin.”

The NICE appraisal committee will now re-assess the evidence for inotuzumab ozogamicin before issuing a second Final Appraisal Determination.

Inotuzumab ozogamicin is an antibody drug conjugate approved by the European Medicines Agency (EMA) for patients with Philadelphia chromosome positive (Ph+) and Philadelphia chromosome negative (Ph-) relapsed or refractory CD22-positive B-cell ALL. It is a medicine that could fulfill significant unmet needs for patients with relapsed or refractory ALL, particularly those with Ph+ disease.

ALL is an aggressive type of leukaemia that can be fatal within a matter of months if left untreated. It is a rare disease, with around 760 people in the UK being diagnosed every year.

The goal of treatment in relapsed or refractory ALL is to achieve complete remission and enable the patient to have a potentially curative stem cell transplant.

Currently, there are few treatment options that can achieve complete remission, and patients have a very poor prognosis. In adult patients with R/R ALL, median overall survival is just three to six months.
 
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-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.

Inotuzumab ozogamicin is administered by intravenous infusion over one hour, providing patients with the option to be administered as an outpatient for one hour a week; thereby potentially helping to alleviate hospital-setting pressures and improve quality of life for patients.

Results from the pivotal phase 3 INO-VATE 1022 trial, published in the New England Journal of Medicine, showed that more than 80% of patients with relapsed or refractory ALL achieved complete remission (including complete remission with incomplete haematological recovery) with inotuzumab ozogamicin treatment vs only 29.4% of patients treated with investigator’s choice standard intensive chemotherapy.

When compared to chemotherapy, nearly four times as many patients were able to receive a stem cell transplant with inotuzumab ozogamicin immediately following treatment.

Inotuzumab ozogamicin received European Marketing Authorisation on 30th June 2017. It was granted orphan drug designation due to the rarity of the disease.

 

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