Regulatory approval

Published by the Health Canada. Approved

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
HC (1) FLT3-ITD Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835Y Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835A Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835E Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835H Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835N Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835S Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.D835V Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
HC (1) FLT3 p.I836del Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals