Authors' objectives: Gemtuzumab ozogamicin (Mylotarg) is intended to be used in combination with chemotherapy for the first line treatment of acute myeloid leukaemia. If licensed, it would offer an additional treatment option for patients with this condition who currently have few well-tolerated effective therapies available. Gemtuzumab ozogamicin is a recombinant humanised anti-CD33 antibody conjugate that is linked to the cytotoxic agent, calicheamicin, which leads to DNA breakage and cell death. Gemtuzumab ozogamicin does not currently have Marketing Authorisation in the EU for any indication. Acute myeloid leukaemia is the most common malignant myeloid disorder in adults, with approximately 2,600 adults diagnosed in the UK each year. In England there were over 2,200 cases of acute myeloid leukaemia in 2011 (representing 3.1 cases per 100,000 population). Acute myeloid leukaemia typically leads to an increased risk of infection, symptomatic anaemia, excessive bleeding, and other symptoms, which greatly reduce patient quality of life. Guidelines recommend that the treatment of acute myeloid leukaemia should be planned with curative intent whenever possible. Azacitidine is currently used as standard treatment for patients with acute myeloid leukaemia who are not eligible for haematopoietic stem cell transplantation. Intensive chemotherapy options may include anthracycline and cytarabine, while non-intensive chemotherapy options (for patients with significant co-morbidity and the elderly who are ineligible for conventional chemotherapy) may include hydroxyurea and low-dose cytarabine. Gemtuzumab ozogamicin in combination with chemotherapy has completed several phase III clinical trials comparing its effect on event-free survival against treatment with chemotherapy alone.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/gemtuzumab-ozogamicin-mylotarg-with-conventional-chemotherapy-for-acute-myeloid-leukaemia-first-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)