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Acute myeloid leukaemia (AML)

 

Australia
Approximately 900 people are diagnosed with AML each year in Australia.1
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FLT3 mutations are among the most common genetic alterations in AML, occurring in about 30% of cases.2
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FLT3 mutations in AML are associated with worse clinical outcomes, including lower remission rates and lower overall survival.3
RYDAPT mechanism of action
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  • Normally, the FLT3 receptor regulates cell growth, but in FLT3 AML, FLT3-ITD and FLT3-TKD mutations drive uncontrolled cell proliferation2
  • RYDAPT is a first-in-class therapy that inhibits multiple tyrosine kinases, including FLT3 and KIT kinases4,5
  • RYDAPT induces cell cycle arrest and apoptosis in leukaemic cells with FLT3-ITD and FLT3-TKD mutations, as well as in cells that overexpress wild type FLT3 receptors4,5

 

AML guideline recommendations
Optimal care pathway for people with AML-2021 Guidelines5
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Endorsed by Australian Government and the Cancer Council
RYDAPT is the only PBS-listed targeted therapy approved to be used in combination with induction chemotherapy for newly diagnosed AML with a FLT3 internal tandem duplication (FLT3-ITD) or tyrosine kinase domain-activating mutation (FLT3-TKD).
NCCN® AML guidelines 20246
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Efficacy
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Safety
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Dosing
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aRATIFY: Phase 3 trial, 717 patients with newly diagnosed AML and a FLT3 mutation were randomly assigned to receive standard chemotherapy (induction therapy with daunorubicin and cytarabine and consolidation therapy with high-dose cytarabine) plus either RYDAPT or placebo; those who were in remission after consolidation therapy entered a maintenance phase in which they received either RYDAPT or placebo. The primary endpoint was OS.7

AE, adverse event; AML, acute myeloid leukaemia; CI, confidence interval; FLT3, FMS-like tyrosine kinase; FLT3-ITD, FMS-like tyrosine kinase internal tandem duplication; FLT3-TKD, FMS-like tyrosine kinase tyrosine kinase domain-activating mutation; HR, hazard ratio; ITD, internal tandem duplication; KIT, tyrosine-protein kinase KIT; mo, months; NCCN, The National Comprehensive Cancer Network; NR, not reached; OS, overall survival; PBS, Pharmaceutical Benefits Scheme; SAE, serious adverse event; TKD, tyrosine kinase domain.

REFERENCES: 1. Leukaemia Foundation. Acute Myeloid Leukaemia (AML). https://www.leukaemia.org.au/blood-cancer/types-of-blood-cancer/leukaemia/acute-myeloid-leukaemia. Accessed October 2024. 2. Daver N et al. Leukemia 2019; 33(2): 299–312. 3. Jalte M et al. Cureus 2023; 15(9). doi:10.7759/cureus.45765. 4. RYDAPT (midostaurin) Australian approved product information. 5. Cancer Council Victoria and Department of Health Victoria. Optimal care pathway for people with acute myeloid leukaemia. 2021. 2nd edn, Cancer Council Victoria, Melbourne. 6. National Comprehensive Cancer Network®. Acute Myeloid Leukemia. 2024. Available at https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed October 2024. 7. Stone RM et al. NEJM 2017; 377(5): 454–64.

RYDAPT PBS Information: This product is listed on the PBS as a Section 100 item. Refer to PBS Schedule for full authority information.

blacktriangleRYDAPT is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

 

For RYDAPT prescribing information, please click here.

This content is intended for Australian healthcare professionals and is promotional.

AU-27528, December 2024