According to a commentary, two major lessons must be learnt from this and previous trials in the same population. First, randomised trials in patients with relapsed or refractory acute myeloid leukaemia (AML) are difficult to undertake because of the heterogeneity of the patient population in terms of previous therapy, responsiveness, and subsequent therapeutic algorithms. Second, the past decade has shown that AML is a very heterogeneous disease that is unlikely to respond in a uniform pattern to a non-targeted therapeutic approach. The commentator believes that vosaroxin represents an innovation that should be further tested within clinical trials and licensing of this drug would be an important step to increase the therapeutic options against this aggressive disease. He suggests that vosaroxin will probably take a place in future therapeutic algorithms, but is unlikely to become a one-size-fits-all treatment, as cytarabine and anthracyclines had been for decades, but more likely a combination partner for somewhat more targeted approaches in well-defined subgroups of patients with AML.
The company is expecting to submit a Marketing Authorisation Application to the European Medicines Agency at the end of 2015 seeking approval of vosaroxin, in combination with cytarabine for the treatment of relapsed or refractory AML.