Rydapt (midostaurin) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Novartis Europharm Ltd. Rydapt (midostaurin) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rydapt-epar-product-information_en.pdf. Revised July 2023. Accessed March 22, 2024.

Regulatory approvals

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

Indication	Statements
Rydapt is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive.	1

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