For Healthcare Professionals outside the US

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, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive.

 

RYDAPT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).

TEST

promptly for FLT3 ITD and TKD mutations*

    • All patients with AML should be tested early and receive rapid results for both FLT3 ITD and TKD mutations in order to be eligible to start induction with multikinase targeted FLT3 therapy1


      *FLT3 mutation testing is performed by the Laboratory of Personalized Molecular Medicine GmbH (Germany), a subsidiary of Invivoscribe Technologies, Inc.

TREAT

with RYDAPT, the first and only multikinase targeted inhibitor approved for newly diagnosed AML in patients with FLT3 ITD/TKD mutations2

  • When used in all 3 phases of treatment, RYDAPT may help improve outcomes
  • For dosing instructions, please see the RYDAPT Summary of Product Characteristics

EXTEND AND SUSTAIN

survival with RYDAPT plus standard chemotherapy in newly diagnosed FLT3+ AML2†

  • Significant improvement in OS with a 23% reduction in the risk of death for RYDAPT plus standard chemotherapy over placebo plus standard chemotherapy (HR=0.77; P=.0078)
  • Median OS of 74.7 months with RYDAPT plus standard chemotherapy (95% CI, 31.5-NE) vs 25.6 months with standard chemotherapy plus placebo (95% CI, 18.6-42.9)
  • Achieve extended survival with RYDAPT independent of SCT status

SAFETY PROFILE with RYDAPT plus standard chemotherapy similar to standard chemotherapy plus placebo2

 

  • The most frequent (incidence ≥30%) ADRs in the RYDAPT plus standard chemotherapy arm were febrile neutropenia, nausea, exfoliative dermatitis, vomiting, headache, petechiae, and pyrexia
  • The most frequent (incidence 10%) grade 3/4 ADRs in the RYDAPT plus standard chemotherapy arm were febrile neutropenia, lymphopenia, device-related infection, and exfoliative dermatitis

 

RATIFY: The efficacy and safety of RYDAPT in combination with standard chemotherapy vs placebo plus standard chemotherapy and as single-agent maintenance therapy was investigated in 717 patients (aged 18 to <60 years) in a randomised, double-blind, phase 3 study. Patients with newly diagnosed FLT3-mutated AML as determined by a clinical study assay were randomised (1:1) to receive RYDAPT 50 mg twice daily (n=360) or placebo (n=357) sequentially in combination with standard daunorubicin (60 mg/m2 daily on days 1-3)/cytarabine (200 mg/m2 daily on days 1-7) induction and high-dose cytarabine (3 g/m2 every 12 hours on days 1, 3, 5) consolidation, followed by continuous RYDAPT or placebo treatment according to initial assignment for up to 12 additional cycles (28 days/cycle). The primary endpoint of the study was OS, measured from the date of randomisation until death by any cause. Patients who proceeded to haematopoietic SCT stopped receiving study treatment prior to the start of the SCT conditioning regimen. All patients were followed for survival.2

Standard chemotherapy is induction therapy with cytarabine and daunorubicin, and consolidation therapy with high-dose cytarabine.
ASM, SM-AHN, and MCL are collectively referred to as advanced systemic mastocytosis (advanced SM).

ADR, adverse drug reaction; Cl, confidence interval; FLT3, FMS-like tyrosine kinase 3; HR, hazard ratio; ITD, internal tandem duplication; NE, not estimated; OS, overall survival; SCT, stem cell transplant; TKD, tyrosine kinase domain.

 

References: 1. Döhner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424-447. 2. RYDAPT [Summary of Product Characteristics]. Novartis Pharma AG; 2017.