Rydapt (midostaurin) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Novartis Pharmaceuticals Canada Inc. Rydapt (midostaurin) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00070168.PDF. Revised March 2023. Accessed June 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).	9

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835Y	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835A	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835E	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835H	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835N	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835S	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.D835V	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin
Sensitivity (+)	FLT3 p.I836del	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin