Prescribing information

 

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RYDAPT

For the treatment of adults with newly diagnosed FLT3+ acute myeloid leukaemia (AML) who are eligible for 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 intensive chemotherapy2–4
  • RYDAPT with standard of care* (SOC) vs. placebo with SOC resulted in:
    • Significant increase in overall survival (OS) (median OS 25.6 months with placebo and SOC (95% CI, 31.5–NR) vs. 74.7 months with RYDAPT and SOC (95% CI, 18.6–42.9: p=0.009))†,5
    • 22% relative reduction in risk of death (HR=0.78; 95% CI, 0.63–0.96: p=0.009)‡,5
    • Significant increase in event-free survival (EFS) (median EFS 3.0 months for placebo and SOC (95% CI, 1.9–5.9) vs. 8.2 months for RYDAPT and SOC (95% CI, 5.4–10.7: p=0.002)†,5

From induction through maintenance, make extended overall survival a reality for your patients.1,5

 

Footnotes

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.

* 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.

References

  1. Rydapt Summary of Product Characteristics. Novartis Pharma AG 2018.
  2. Ferrara F, Schiffer CA. Acute myeloid leukaemia in adults. Lancet. 2013;381(9865):484–495.
  3. European Medicines Agency. Rydapt. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt. Last accessed May 2020.
  4. US Food and Drug Administration. RYDAPT approval. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-com.... Last accessed May 2020.
  5. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454–464.
HCP20-C026 June 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]