Inotuzumab Ozogamicin: First Global Approval

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Funding: The preparation of this review was not supported by any external funding.

Conflicts of interest: Yvette Lamb is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here.

Abstract

Intravenous inotuzumab ozogamicin (Besponsa®; Pfizer) is an anti-CD22 monoclonal antibody-calicheamicin conjugate that binds to CD22-expressing tumour cells. Upon binding, the complex is internalised and the cytotoxic calicheamicin derivative is released inside the cell, inducing double-stand DNA breakage and subsequent cell death. The EMA has granted inotuzumab ozogamicin approval 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 CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor. A phase III trial evaluating inotuzumab ozogamicin in combination with frontline chemotherapy in adults with newly diagnosed B-cell ALL has recently been initiated in the US. Inotuzumab ozogamicin is under a US phase II clinical trial in childhood CD22-positive B-cell ALL and phase I/II trial in post-transplant CD22-positive ALL. In the US, inotuzumab ozogamicin combination therapies are also being evaluated in the phase I/II setting in ALL and chronic myeloid leukaemia and in the phase I setting in Burkitt’s lymphoma. This article summarises the milestones in the development of inotuzumab ozogamicin leading to this first approval for ALL. .Access to the full article can be found here.

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