Rydapt Approval History

• FDA approved: Yes (First approved April 28th, 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

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

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