Rydapt (midostaurin) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Novartis Pharmaceuticals Corporation. Rydapt (midostaurin) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207997s010lbl.pdf. Revised May 2023. Accessed October 30, 2024.

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Regulatory approvals

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

Indication Statements
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation- positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. 10

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
FDA (1) FLT3-ITD Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835Y Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835A Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835E Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835H Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835N Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835S Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.D835V Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) FLT3 p.I836del Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin
FDA (1) CDK12 oncogenic variants Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin