Bristol-Myers Squibb (BMS ) has secured approval from the European Commission (EC) for the use of its Sprycel (dasatinib) to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).
In addition to chronic phase (CP) patients aged between one and 18 years, the authorisation covers a powder for oral suspension formulation of the drug.
The European regulatory decision comes after the review of results from the Phase II CA180-226 trial conducted to investigate the safety and efficacy of Sprycel in paediatric patients who were newly diagnosed with CP-CML and in those subjects resistant to or intolerant of imatinib.
Data showed patients resistant to or intolerant of imatinib achieved 55.2% cumulative major cytogenetic response (MCyR) rate at three months into treatment with Sprycel.
In newly diagnosed patients, a cumulative complete cytogenetic response (CCyR) rate of 64% was observed six months into treatment.
The trial also met its secondary endpoint with more than 75% and 90% of estimated progression-free survival at 48 months in patients resistant to or intolerant of imatinib and those who received the drug as a first-line therapy, respectively.
Bristol-Myers Squibb Oncology development head Fouad Namouni said: “Treatment options for paediatric patients with CML are limited, as are formulations that correspond with the unique demands of children with cancer.
“Our decision to pursue an expanded indication for Sprycel in this new patient population and as a new formulation is indicative of our commitment to extending the potential of our medicines to address the unmet needs of patients with cancer, regardless of the incidence of the disease.”
Sprycel is a tyrosine kinase inhibitor and obtained approval from the US Food and Drug Administration (FDA) in 2006 for adults with Ph+ CML in chronic phase and resistant or intolerant to previous therapy.
The FDA also expanded the indication for adults suffering from Ph+ acute lymphoblastic leukaemia (ALL) who are resistant or intolerant to prior therapy and those newly diagnosed with Ph+ CML-CP.
Last year, the regulator authorised Sprycel for treating paediatric Ph+ CML-CP patients.