Midostaurin - Novartis Oncology

Drug Profile

Midostaurin - Novartis Oncology

Alternative Names: 4-N-benzoyl staurosporine; Benzoylstaurosporine; CGP 41251; N-benzoyl-staurosporine; PKC412; PKC412A; Rydapt

Latest Information Update: 15 Mar 2018

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At a glance

  • Originator Novartis
  • Developer Mayo Clinic; National Cancer Institute (USA); Novartis; Novartis Oncology; Ohio State University Comprehensive Cancer Center
  • Class Antineoplastics; Carbazoles; Eye disorder therapies; Indole alkaloids; Skin disorder therapies; Small molecules
  • Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Multidrug resistance-associated protein inhibitors; Platelet-derived growth factor receptor antagonists; Protein kinase C inhibitors; Proto oncogene protein c-kit inhibitors; Signal transduction pathway inhibitors; Vascular endothelial growth factor receptor-2 antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Acute myeloid leukaemia; Systemic mastocytosis
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Acute myeloid leukaemia; Systemic mastocytosis
  • Discontinued Acute biphenotypic leukaemia; Colorectal cancer; Diabetic macular oedema; Gastrointestinal stromal tumours; Multiple myeloma

Most Recent Events

  • 17 Jan 2018 Novartis completes an expanded access programme for Acute myeloid leukaemia in Canada and Portugal (NCT03114228)
  • 09 Jan 2018 Midostaurin is not yet launched for Acute myeloid leukaemia (Combination therapy, First-line therapy) and Systemic mastocytosis in USA (PO) (Novartis product portfolio, January 2018)
  • 18 Dec 2017 Phase-III clinical trials in Acute myeloid leukaemia (Newly diagnosed, In adults, In the elderly, Combination therapy) in Finland and Hungary (PO) (EudraCT2016-004440-12)
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