Chronic myelogenous leukaemia (CML) Philadelphia chromosome positive (Ph+)

Active Ingredient: Dasatinib

Indication for Dasatinib

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Dasatinib is indicated for the treatment of adult patients with:

  • newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
  • Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Dasatinib is indicated 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.
  • newly diagnosed Ph+ ALL in combination with chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments:

40-100 mg once daily

Route of admnistration

Oral

Defined daily dose

40 - 100 mg

Dosage regimen

From 40 To 100 mg once every day

Detailed description

Dosing for children and adolescents is on the basis of body weight (see Table 1). Dasatinib is administered orally once daily. The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. There is no experience with dasatinib treatment in children under 1 year of age.

The recommended starting daily dosage of dasatinib tablets in paediatric patients is shown in Table 1.

Table 1. Dosage of dasatinib tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL:

Body weight (kg)a Daily dose (mg)
10 to less than 20 kg 40 mg
20 to less than 30 kg 60 mg
30 to less than 45 kg 70 mg
at least 45 kg 100 mg

Treatment duration

In clinical studies, treatment with dasatinib in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.

In clinical studies, treatment with dasatinib in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years. In patients that receive a subsequent stem cell transplantation, dasatinib can be administered for an additional year post-transplantation.

Dose escalation

In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.

The following dose escalations shown in Table 2 are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment.

Table 2. Dose escalation for paediatric patients with Ph+ CML-CP:

 Dose (maximum dose per day)
Starting dose Escalation
Tablets 40 mg 50 mg
60 mg 70 mg
70 mg 90 mg
100 mg 120 mg

Dose escalation is not recommended for paediatric patients with Ph+ ALL, as dasatinib is administered in combination with chemotherapy in these patients.

Dosage considerations

Dasatinib can be taken with or without a meal and should be taken consistently either in the morning or in the evening.

Active ingredient

Dasatinib

Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor. Dasatinib is a potent, subnanomolar inhibitor of the BCR-ABL kinase with potency at concentration of 0.6-0.8 nM. It binds to both the inactive and active conformations of the BCR-ABL enzyme.

Read more about Dasatinib

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