Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Midostaurin

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-09-18	European Medicines Agency	Indication received approval from the European Commission.