Cost regulators for the NHS in England and Wales have now published final guidelines recommending Mylotarg, alongside daunorubicin and cytarabine, as an option for untreated de novo CD33-positive acute myeloid leukaemia (AML).
The guidelines, which do not cover the treatment of acute promyelocytic leukaemia, endorse NHS funding for patients aged 15 years and over, but only if they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is, because the test was unsuccessful) or when their cytogenetic test results are not yet available, and they start consolidation therapy when cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful).
Also, the recommendation is contingent upon the continued provision of Mylotarg (gemtuzumab ozogamicin) according to the commercial arrangement.
Mylotarg is a targeted therapy consisting of an antibody connected to an anti-tumor agent that is toxic to cells, and thought to work by taking the anti-tumour agent to the AML cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.
The treatment won European approval in May this year after clinical trials showed 81 percent of patients taking the drug reached remission, and that Mylotarg in combination with chemotherapy offers a statistically significant and meaningful improvement in median event-free survival versus chemotherapy alone (17.3 months and 9.5 months, respectively).