FDA approved Sprycel (dasatinib) for Philadelphia Chromosome-Positive LeukemiasFDA approved Sprycel, a New Oral Drug for Several Types of Leukemia

Dasatinib is a kinase inhibitor. The exact mechanism of action is not fully described in the label.

Dasatinib tablets are indicated for: - Adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. - Adult patients with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. - Adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. - Pediatric patients 1 year of age and older with Ph+ CML in chronic phase. - Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

- Administer orally, with or without a meal, either in the morning or evening. Do not crush, cut, or chew tablets; swallow whole. - Adult chronic phase CML: 100 mg once daily. - Adult accelerated phase CML, myeloid or lymphoid blast phase CML, or Ph+ ALL: 140 mg once daily. - Pediatric patients: starting dose based on body weight (see Table 1). Recalculate dose every 3 months based on weight changes, or more often if necessary. Tablet dosing not recommended for patients weighing less than 10 kg. For pediatric Ph+ ALL, begin dasatinib on or before day 15 of induction chemotherapy and continue for 2 years. - Dose escalation: For adults with CML or Ph+ ALL who do not achieve hematologic or cytogenetic response at starting dose, consider escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL). For pediatric CML, consider escalation to 120 mg once daily. Dose escalation not recommended for pediatric Ph+ ALL. - Strong CYP3A4 inducers: Avoid concomitant use. If coadministration necessary, consider dose increase and monitor for toxicity. - Strong CYP3A4 inhibitors: Avoid concomitant use. If coadministration necessary, consider dose reduction (40 mg daily for patients on 140 mg, 20 mg daily for patients on 100 mg or 70 mg; for 60 mg or 40 mg daily, consider interrupting dasatinib until inhibitor discontinued, with ~1 week washout before reinitiating).

Trial data not available in label.

The label text provided does not include warnings, precautions, or contraindications. Not reported in label.

Dasatinib is an oral kinase inhibitor approved for multiple Ph+ leukemia indications, including newly diagnosed chronic phase CML, advanced phase CML and Ph+ ALL resistant or intolerant to prior therapy, and pediatric Ph+ CML and Ph+ ALL. The availability of weight-based pediatric dosing and combination use with chemotherapy in Ph+ ALL provides additional treatment options. Clinical decisions should consider prior therapy, disease phase, and potential drug interactions.