Rydapt

Midostaurin

• Brand(s): Rydapt
• Dosage Form/Strength: 25 mg capsule

For the treatment of adult patients diagnosed with FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) who meet ALL the following criteria:

1. FLT3 mutation is confirmed by an approved test; AND

2. Midostaurin is used as first-line¹ for FLT3-mutated AML; AND

3. Midostaurin is used in combination with standard induction chemotherapy with cytarabine and daunorubicin followed by standard consolidation chemotherapy with cytarabine OR any 7+3 induction regimen containing idarubicin followed by standard consolidation chemotherapy with cytarabine.

Exclusion criteria:

Midostaurin will not be funded in the following situations:

• As maintenance therapy for AML;
• Patients who have developed therapy-related AML after radiation therapy or chemotherapy for another cancer or disorder;
• Patients receiving other induction chemotherapy regimens aside from those mentioned in the eligibility criteria or upon finishing the consolidation phase of treatment;
• Patients undergoing re-induction and/or re-consolidation.

Recommended Dose(s):

• Induction dose: Midostaurin 50 mg twice daily on Days 8 to 21 with each cycle of induction cytarabine and daunorubicin.
  A maximum of 2 induction cycles may be funded. (Note: EAP only considers funding of outpatient midostaurin usage)*
• Consolidation phase: Midostaurin 50 mg twice daily on days 8 to 21 of each cycle of consolidation with cytarabine.
  A maximum of 4 consolidation cycles may be funded by EAP (for cycles administered as an outpatient)*

Up to 2 cycles of induction and 4 cycles of consolidation may be funded in accordance with patient response to therapy*

Approval duration: Up to 6 months (maximum of 2 cycles of induction and 4 cycles of consolidation)*

¹For a short-term, time limited period, the Ministry will consider requests from prescribers who wish to add midostaurin to their patients’ current regimens that have been initiated prior to the provincial funding of midostaurin. To be considered, patients must currently be on standard induction and consolidation chemotherapy, and have not experienced disease progression or unacceptable intolerance during the first-line treatment with the standard chemotherapies being used.

*EAP will provide coverage for midostaurin administered in the outpatient setting (e.g., consolidation cycles). Those responding to induction therapy may require ongoing access to midostaurin for the consolidation phase of treatment upon discharge from the hospital.

EAP Drug Request Form:

Standard Form for EAP Drug Requests