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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

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

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