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Please note that RYDAPT®▼ (midostaurin) is not subject to additional monitoring in Northern Ireland.
RYDAPT
For the treatment of adults with newly diagnosed FLT3+ acute myeloid leukaemia (AML) who are eligible for select intensive chemotherapy.1
Indication
RYDAPT is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by RYDAPT single agent maintenance therapy, in adult patients with newly diagnosed AML who are FLT3 mutation positive.1
Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (ITD or TKD) using a validated test.
What is RYDAPT?
RYDAPT is an oral protein kinase inhibitor of multiple receptor tyrosine kinases, including FLT3 and KIT kinase. Inhibition of FLT3 receptor signalling induces cell cycle arrest and apoptosis in leukaemic cells.1
- RYDAPT is the first and only FLT3 inhibitor approved for newly diagnosed FLT3+ AML patients eligible for select intensive chemotherapy3–6
- RYDAPT with standard of care* (SOC) vs placebo with SOC resulted in:
- Significant increase in overall survival (OS): Median OS with RYDAPT + SOC was 74.7 months (95% CI, 31.5–NR) vs 25.6 months with placebo and SOC (95% CI, 18.6–42.9: p=0.009)†2
- 22% relative reduction in risk of death (HR=0.78; 95% CI, 0.63–0.96: p=0.009)‡2
- Significant increase in event-free survival (EFS): Median EFS 8.2 months for RYDAPT and SOC (95% CI, 5.4–10.7) vs 3.0 months for placebo and SOC (95% CI, 1.9–5.9: p=0.002)†2
For maintenance therapy, make extended overall survival a possibility for your eligible patients.1,2
*SOC: Chemotherapy dosing during induction was cytarabine IV, 200 mg/m2/d on Days 1–7, and daunorubicin IV, 60 mg/m2/d on Days 1–3. During consolidation, high-dose cytarabine was given at a dose of 3 g/m2/d IV q12h on Days 1, 3 and 5.
†One-sided p by stratified log-rank test.
‡One-sided p by stratified score test.
AML, acute myeloid leukaemia; CI, confidence interval; EFS, event-free survival; HR, hazard ratio; ITD, internal tandem duplication; IV, intravenous; NR, not reached; q12h, every 12 hours; SOC, standard of care; TKD, tyrosine kinase domain.
References
- Rydapt Summary of Product Characteristics. Novartis Pharma AG 2022.
- Stone RM, et al. N Engl J Med 2017;377(5):454–464.
- Ferrara F & Schiffer CA. Lancet 2013;381(9865):484–495.
- European Medicines Agency. Rydapt. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt. [Accessed September 2023].
- US Food and Drug Administration. RYDAPT approval. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-com.... [Accessed September 2023].
- Zhao J, et al. Blood Rev 2022;52:100905.
