EC approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of paediatric patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This is the second paediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for paediatric patients with ALL in Europe, the powder for oral suspension (PFOS) formulation of Sprycel.
It says that the approval is based on data from CA180-372 (NCT01460160), a Phase 2 trial which evaluated the addition of Sprycel to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone in paediatric patients with newly-diagnosed Ph+ ALL. Results from the CA180-372 trial presented at the 2017 American Society of Hematology Annual Meeting showed that at three years, the combination of Sprycel and chemotherapy demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5).
BMS state that the safety profile of Sprycel administered in combination with chemotherapy in paediatric patients with Ph+ ALL in the CA180-372 trial was consistent with the known safety profile of Sprycel in adults with Ph+ ALL and the known safety profile of the chemotherapy regimen. Primary toxicities of any causality included haematological toxicity such as grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%) and bacteremia (24.5%). Non-haematologic, non-infectious grade 3 or 4 adverse events (AEs) attributed to Sprycel and reported in more than 10% of patients were limited to elevated alanine aminotransferase (21.7%) and aspartate transaminase (10.4%). Other grade 3 or 4 AEs attributed to Sprycel were pleural effusion (3.8%), oedema (2.8%), haemorrhage (5.7%) and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported.
It adds that patients treated in the study (n=106), all aged younger than 18 years, received Sprycel at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to 24 months, in combination with chemotherapy. Seventy-seven percent of patients (N=82) received Sprycel tablets exclusively, and 23% of patients (N=24) received Sprycel PFOS at least once.
“We are proud that the approval by the European Commission brings children with Ph+ acute lymphoblastic leukemia a new treatment option, including a powder formulation developed as part of our commitment to addressing the unique needs of children with cancer,” said Fouad Namouni, M.D., Head, Oncology Development, Bristol-Myers Squibb.