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.

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.

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
Sensitivity (+)	CDK12 oncogenic variants	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin