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NICE recommends Pfizer's Mylotarg combo in CD33-positive acute myeloid leukaemia

Published on 08/10/18 at 11:46am

NICE has revealed its recommendation for Pfizer’s Mylotarg (gemtuzumab ozogamicin) to be used on the NHS in the treatment of previously untreated, de novo, CD33-positive acute myeloid leukaemia (AML).

The organisation has backed the drug’s use in combination with chemotherapies daunorubicin and cytarabine in patients older than 15 with intermediate cytogenetics, adding to the recommendations of earlier draft guidelines which advised it be used in those with favourable or unknown cytogenetics.

“Over the past few decades, there has been little innovation in how we treat AML,” said haematologist Professor Nigel Russell from the Centre for Clinical Haematology, Nottingham University Hospital Trust.  “Despite slow improvements in outcomes, the prognosis for patients with this type of blood cancer remains poor. Gemtuzumab ozogamicin is a targeted therapy that is given with standard chemotherapy and prolongs the time spent in remission compared to standard treatments. It provides a welcome addition to the treatment options for eligible patients with AML and is an important step towards ensuring that some very sick blood cancer patients can access appropriate treatments to achieve a prolonged, complete remission.”

Mylotarg was approved for use in the EU in May earlier this year after demonstrating that 81% of users achieved remission, with a 17-month improvement in median event-free survival versus 9.5 months for chemotherapy alone.

Craig Eagle, Head of Oncology at Pfizer UK, added: “We welcome NICE’s final decision to recommend gemtuzumab ozogamicin for eligible patients living with AML. Pfizer has worked tirelessly with the AML community to ensure patients in the UK have access to appropriate treatment options and this important, potentially life-changing medicine offers renewed hope for some people living with AML in England and Wales.”

Matt Fellows

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