Skip to Content

Rydapt Approval History

FDA Approved: Yes (First approved April 28, 2017)
Brand name: Rydapt
Generic name: midostaurin
Dosage form: Capsules
Previous Name: PKC412
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Myeloid Leukemia, Cutaneous Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

Development History and FDA Approval Process for Rydapt

DateArticle
Apr 28, 2017Approval FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis
Nov 14, 2016Novartis drug PKC412 (midostaurin) Granted FDA Priority Review for Newly-Diagnosed FLT3-Mutated AML and Advanced Systemic Mastocytosis
Jun 30, 2016Novartis PKC412 (midostaurin) Pivotal Data Published in NEJM Show 60% Response Rate in Advanced Systemic Mastocytosis (SM)
Feb 19, 2016Novartis Drug PKC412 (midostaurin) Receives Breakthrough Therapy Designation from the FDA for Newly-Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML)
Dec  6, 2015Novartis Drug PKC412 (midostaurin) Improves Overall Survival by 23% in Global Phase III Study of AML Patients with FLT3 Mutations

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide