Inotuzumab Ozogamicin: First Global Approval

<div>Compliance with Ethical Standards</div><div><br></div><div><i>Funding:</i> The preparation of this review was not supported by any external funding.</div><div><br></div><div><i>Conflicts of interest: </i>Yvette Lamb is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest. </div><div><br></div><div>Additional information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>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 <a href="https://link.springer.com/article/10.1007/s40265-017-0802-5"><b>here.</b></a></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017</div>