Regulatory approval

Published by the Health Canada.

Health Canada approved midostaurin in combination with cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

This is written in the approval document as:

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).

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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