Information on how to access Mylotarg®▼(gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting can be found at the bottom of the page.
In this video, Professor Venditti presents the pivotal, randomised Phase III study (ALFA-0701) for Mylotarg in the treatment of CD33+ de novo Acute Myeloid Leukaemia. He discusses the regulatory approvals for the Mylotarg alongside its dosing and schedule in combination with daunorubicin and cytarabine within the ALFA-0701 study. He discusses efficacy endpoints of event free survival (primary endpoint for the ALFA-0701 study) and relapsed free survival for the treatment arm vs the control arm. He also mentions the clinical characteristics of the patients within the study and then goes on to discuss the adverse events seen in both arms, including veno-occlusive disease and prolonged thrombocytopenia. Finally, Professor Venditti discusses the outcomes of patients in the ALFA-0701 study who proceeded to allogeneic stem cell transplant and also the analysis of MRD negativity in patients who were NPM1 positive.
Professor Adriano Venditti has been an Associate Professor in Haematology at the University of Rome Tor Vergata since 2001 and is now a UOSD director at the Polyclinic Tor Vergata Foundation. He graduated from the Sapienza University of Rome in 1986 with a degree in medicine and surgery, and went on to specialise in haematology, completing two UK fellowships - in the Department of Immunology at the Royal Free Hospital in London as a CNR scholarship winner, and later at the Department of Haematology and Cytogenetics at the Royal Marsden NHS Foundation Trust, London, UK. Prof. Venditti has been board-certified in haematology since 1989 and has authored over 200 publications in peer-reviewed journals.
Prof. Venditti’s main fields of interest include acute leukaemia, MDS, and chronic myeloproliferative disorders. He is the national coordinator of the AML1310 protocol for the treatment of adult patients aged <60 years with acute myeloid leukaemia. He is an elected member of the board of the Italian Society of Haematology and is a member of both the GIMEMA and EORTC acute leukaemia working parties.
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AML, Acute Myeloid Leukaemia; EORTC, European Organisation for Research and Treatment of Cancer; GIMEMA, Gruppo Italiano Malattie EMatologiche dell’Adulto (the Italian Adult Haematological Diseases Group); MDS, Myelodysplastic syndrome; MRD, minimal residual disease; NPM1, Nucleophosmin 1
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
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