NICE recommends Pfizer's Besponsa.

M2 EQUITYBITES-August 10, 2018-NICE recommends Pfizer's Besponsa

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The National Institute for Health and Care Excellence (NICE) has reversed its draft decision rejecting Pfizer's Besponsa (inotuzumab ozogamicin) as a treatment for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL), Pharma Times reported on Thursday.

Following a successful appeal from Pfizer, the drug will now be available on the NHS in England and Wales.

Besponsa is an antibody drug conjugate that is comprised of a monoclonal antibody that targets CD22, a cell surface antigen expressed on around 90% of B-cell malignancies, linked to a cytotoxic agent. It binds to CD22 on malignant B-cells and is then taken into the cell, where the cytotoxic agent calicheamicin is released to destroy it.

Data from the INO-VATE trial, which compared the drug to standard of care chemotherapy in 326 adult patients with relapsed or refractory CD22-positive ALL, demonstrated that the therapy more than doubled complete remission rates.

In June last year, NICE released draft guidelines which argued that evidence from clinical trials showed no survival benefit compared to current treatment. However, the body did note that more patients receiving Besponsa were able to subsequently have a stem cell transplant and go into remission than those on standard care.

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