FDA approved Phyrago (dasatinib) for Philadelphia Chromosome-Positive LeukemiasFDA approved Phyrago, a New Option for Some Leukemias

Phyrago is a kinase inhibitor. The exact mechanism of action is not fully described in the label, but it is indicated for the treatment of Philadelphia chromosome-positive (Ph+) leukemias, suggesting inhibition of BCR-ABL kinase.

Phyrago is indicated for: - Adult patients with newly diagnosed Ph+ 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 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.

- Adult chronic phase CML: 100 mg orally once daily. - Adult accelerated phase, myeloid or lymphoid blast phase CML, or Ph+ ALL: 140 mg orally once daily. - Pediatric patients: starting dose based on body weight (see Table 1 in label). Recalculate dose every 3 months based on weight changes. - Administer with or without a meal. Swallow tablets whole; do not crush, cut, or chew. - Dosage modifications for drug interactions: - Strong CYP3A4 inducers: avoid concomitant use; if unavoidable, consider dose increase with careful monitoring. - Strong CYP3A4 inhibitors: avoid concomitant use and grapefruit juice; if unavoidable, reduce dose (e.g., to 40 mg daily for patients on 140 mg, 20 mg daily for those on 100 mg or 70 mg; for 60 mg or 40 mg, consider interrupting Phyrago until inhibitor discontinued). Allow approximately 1 week washout after inhibitor stopped before reinitiating. - Antacids: avoid concomitant use; if needed, administer antacid at least 2 hours before or after Phyrago. - 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.

Trial data not available in label.

The label does not provide specific warnings, precautions, or contraindications in the provided text. Please refer to the full prescribing information for complete safety information.

Phyrago is a kinase inhibitor approved for multiple Ph+ leukemia indications, including newly diagnosed chronic phase CML, resistant/intolerant CML and Ph+ ALL, and pediatric patients. It offers an oral treatment option with weight-based dosing for children and fixed dosing for adults. The label does not include comparative efficacy or safety data; therefore, its place in therapy relative to other agents should be guided by clinical guidelines and patient-specific factors.