Rydapt (midostaurin)

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Rydapt (midostaurin)

Manufacturer Novartis
Disease Blood Cancer
Indication FLT3 mutation-positive acute myeloid leukemia (AML); Systemic mastocytosis
Mode of Action Kinase inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA)
Strength 25 mg

Who is midostaurin for?

Rydapt (midostaurin) is indicated for the treatment of patients with
  • Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation positive as detected by an FDA-approved test, in combination with chemotherapy (standard cytarabine and daunorubicin induction and cytarabine consolidation). RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
  • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) [1][3].

Recommended dose

Complete information about Rydapt (midostaurin) dosage and administration can be found here [1][3].
The standard dosage for AML is:
  • 50 mg (2 capsules) orally twice daily with food
The standard dosage for ASM, SM-AHN, and MCL is:
  • 100 mg (4 capsules) orally twice daily with food.
Consult your treating doctor for personalised dosing.

What is midostaurin and how does it work?

Rydapt (midostaurin) is a kinase inhibitor indicated for the treatment of adult patients with
  • Newly diagnosed FLT3 mutation positive acute myeloid leukemia (AML), detected by an FDA-approved test, in combination with chemotherapy. Midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML.
  • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) [1][3].
The active substance in Rydapt is midostaurin, a kinase inhibitor that works by blocking several enzymes that promote cell growth [2][4].
Midostaurin demonstrated the ability to inhibit FLT3 receptor signaling and cell proliferation, and it induced apoptosis in leukemic cells expressing ITD and TKD mutant FLT3 receptors or overexpressing wild type FLT3 and PDGF receptors. Midostaurin also demonstrated the ability to inhibit KIT signaling, cell proliferation, and histamine release and induce apoptosis in mast cells [1][4].

What is midostaurin’s approval status?

Rydapt (midostaurin) was approved by:
  • FDA (USA) on April 28, 2017
  • EMA (EU) on October 25, 2017
for patients newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy; and for patients with systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) [1][3].
The safety and efficacy of Rydapt (midostaurin) for patients with AML  was based on a study involving 717 previously untreated patients. Although a specific median survival rate could not be reliably estimated it emerged that patients who received Rydapt (midostaurin) in combination with chemotherapy lived longer than patients who received chemotherapy alone. In addition, patients who received Rydapt (midostaurin) in combination with chemotherapy lived for a median of 8.2 months without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia or death), compared with a median of 3 months in patients who received chemotherapy alone [2][3].
Among the common side effects in patients with AML are low levels of white blood cells with fever (febrile neutropenia), nausea and inflammation of the mucous membranes (mucositis) [1].
The safety and efficacy of Rydapt (midostaurin) for patients with advanced systemic mastocytosis (SM) was based on a main study that enrolled 116 adult patients with relapse or progression to 0, 1, or 2 prior regimens for SM, of which 89 were considered as evaluable for response [1][3]. Of these, 21 % achieved complete (CR) or incomplete remission (ICR) within 6 cycles, and the effect lasted for an estimated median of 35.4 months (range: 6.6+, 65.8+). The median time to response was 0.5 months and ranged from 0.1 to 3.0 months [1]. The efficacy of midostaurin was confirmed in other patient groups as well [1].
Among the patients with ASM, SM-AHN, or MCL the most common adverse reactions (≥ 20%) were nausea, vomiting, diarrhea, edema, musculoskeletal and abdominal pain [1].
References
[1] Summary of Product Characteristics [FDA]: Rydapt (midostaurin), Novartis Pharma Co., Apr. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207997s000lbl.pdf
[2] FDA News Release. FDA approves new combination treatment for acute myeloid leukemia, 28/04/2017.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm555778.htm
[3] Summary of Product Characteristics [EMA]: Rydapt (midostaurin), Novartis Pharma Co., Oct. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004095/WC500237581.pdf
[4] EMA. Human medicines: Rydapt (midostaurin)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004095/human_med_002155.jsp&mid=WC0b01ac058001d124

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.








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