ISSUE 1547
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The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.
RELAPSED OR REFRACTORY ALL — Induction chemotherapy induces a complete remission in 60-90% of adults with newly-diagnosed ALL, but most of these patients will subsequently relapse. The goal for patients who do not respond to induction therapy and those who respond initially and then relapse is to achieve a complete remission, or close to it, in order to proceed to an allogeneic hematopoietic cell transplant (HCT), which can be curative.1
MECHANISM OF ACTION — The antibody-drug conjugate binds to CD22, which
... more- PA Brown et al. NCCN guidelines insights: acute lymphoblastic leukemia, version 1.2017. J Natl Compr Canc Netw 2017; 15:1091.
- Blinatumomab (Blincyto) for acute lymphoblastic leukemia. Med Lett Drugs Ther 2015; 57:e74.
- Tisagenlecleucel (Kymriah) for ALL. Med Lett Drugs Ther 2017; 59:177.
- HM Kantarjian et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med 2016; 375:740.
- H Kantarjian et al. Inotuzumab ozogamicin in combination with low-intensity chemotherapy for older patients with Philadelphia chromosome-negative acute lymphoblastic leukaemia: a single-arm, phase 2 study. Lancet Oncol 2018; 19:240.
- RL Woosley and KA Romero. QT drugs list. Available at www.crediblemeds.org. Accessed May 10, 2018.
- Approximate WAC for a patient with a 1.7 m2 surface area. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. May 5, 2018. Reprinted with permission by First Databank, Inc. All rights reserved. ©2018. www.fdbhealth.com/policies/drug-pricing-policy.
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