Only anecdotal evidence of safety which indicates no effects in one breastfed infant

Serious adverse effects reported in adults

Jul 18 · Approved in EU for ´treatment of children and adolescents aged 1 - years with Philadelphia positive CP-CML in chronic phase´. A powder for oral suspension formulation is also approved [6].

Apr 18 · Recommended for approval by CHMP: the additional indication is "for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML‑CP) or Ph+ CML‑CP resistant or intolerant to prior therapy including imatinib" [5].

Jul 17 · Supplementary NDA accepted for priority review by FDA with target action date of 9/11/17. Application includes data from from CA180-226 (NCT00777036) [3].

May 17 · EMA have validated a type II variation application for dasatinib to treat children (aged 1 - 18 years) with Philadelphia positive CP-CML, and for dasatinib powder for oral suspension. Validation of the application begins the EMA’s centralized review process [4].

Annual incidence of CML is between 1 and 2 cases per 100,000. Presentation can occur at any age; however, it is rare in children (CML represents only 5% of childhood leukaemia) [2].

Jul 17 · PII (NCT00777036) study to determine whether treatment with dasatinib is effective and safe in children and adolescents with newly diagnosed chronic phase CML (CP-CML) or with philadelphia positive leukemias resistant or intolerant to imatinib is ongoing. 139 children will be recruited from sites worldwide including US & EU (including UK) [1].

Jun 17 · BMS release initial results from NCT00777036. Patients with CP-CML resistant to or intolerant of imatinib who received dasatinib demonstrated a MCyR rate of 55.2% [95% CI 36 to 74]) 3 months into treatment, increasing to >90% [73 to 98) at 24 months. Newly diagnosed patients with CP-CML, achieved a CCyR rate of 64% [53 to 74] as early as 6 months into treatment; increasing to 94% (87 to 98) at 24 months [4].

Jun 17 · Primary endpoint in NCT00777036 is cumulative major cytogenetic response (MCyR) rate for patients with CP-CML resistant to or intolerant of imatinib (threshold of clinical interest >30%). Primary endpoint for newly diagnosed patients with CP-CML is cumulative complete cytogenetic response (CCyR) rate (threshold of clinical interest >55%) [1].

AWMSG

EPAR

Feb 19 · Approved in EU for use in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Ph+ ALL [9].

Jan 19 · Approved by US FDA for treatment of children aged ≥1 year with newly diagnosed disease. The approval is based on data from the phase II study, CA180-372 [8].

Dec 18 · Recommended for EU approval by CHMP - the additional indication is "treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.” [7].

Aug 18 · Filed in US for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). Application is based on data from ongoing PII trial CA180-372 [6].

Dec 05 · Granted orphan designation (EU/3/05/338) by the European Commission for treatment of ALL [3].

Acute leukaemia is an uncommon form of haematological malignancy. About 7,600 people are diagnosed with leukaemia each year in the UK. Of these, only about 650 people have ALL [1].

Aug 18 · Primary data for NCT01460160 collected May 2017. Study active but not recruiting [5].

Dec 16 · Primary data for NCT01460160 due May 2017 [4]

Jan 12 · PII (NCT01460160) study to determine whether dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive ALL starts. 75 children will be recruited from sites worldwide including US & EU (Including UK)> the study is expected to complete collection of primary outcome data (event-free survival rate) in May 17 [2].

EPAR

NIHR

SMC