Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vyxeos · 1 trial · 2 indications
Defined as time from entering the relevant randomisation to the relevant question until death from any cause. Patients who are alive at the end of the trial or have been lost to follow up will be censored at their date last seen. For randomisations 2 and 3 this outcome will also be calculated as time from transplantation in order to run a sensitivity analysis.
| Arm | Type | Description |
|---|---|---|
| R1: Intermediate dose Cytarabine | ACTIVE_COMPARATOR | First Randomisation (closed to recruitment) - control arm: Intermediate dose Cytarabine (1g/m\^2 administered by intravenous infusion over 2 hours on days 1-5 inclusive) |
| R1: Vyxeos | EXPERIMENTAL | First Randomisation (closed to recruitment) - experimental arm: Vyxeos (29mg/65mg/m\^2 administered by intravenous infusion over 90 minutes on days 1 and 3) |
| R2: FB4 | ACTIVE_COMPARATOR | Second Randomisation - under 55 years - control arm: Fludarabine (40mg/m\^2 days -7, -6, -5, and -4), Busulphan (3.2mg/kg days -7, -6, -5 and -4) |
| R2: TBF | EXPERIMENTAL | Second Randomisation - under 55 years - experimental arm: Thiotepa (5mg/kg day -7 and -6), Busulphan (3.2mg/kg days -5, -4 and -3), Fludarabine (50mg/m\^2 days -5, -4 and -3) |
| R3: FB2 | ACTIVE_COMPARATOR | Third Randomisation - 55 years and over (or under 55 with comorbidities) - control arm: Fludarabine (30mg/m\^2 days -6, -5, -4, -3 and -2), Busulphan (3.2mg/kg days -6 and -5) |
| Mini-TBF | EXPERIMENTAL | Third Randomisation - 55 years and over (or under 55 with comorbidities) - experimental arm: Thiotepa (5mg/kg day -6), Busulphan (3.2mg/kg days -5 and -4), Fludarabine (50mg/m\^2 days -5, -4, and -3) |
| Name | Type | Description |
|---|---|---|
| Vyxeos | DRUG | Vyxeos administered by intravenous infusion |
| Fludarabine | DRUG | Fludarabine administered by intravenous infusion |
| Busulphan | DRUG | Busulphan administered by intravenous infusion |
| Thiotepa | DRUG | Thiotepa administered by intravenous infusion |
| Cytarabine | DRUG | Cytarabine administered by intravenous infusion |
Eligibility Criteria for Randomisation 1 (closed to recruitment) Inclusion Criteria for Randomisation 1 1. Patients (≥ 18 years old) with a morphological documented diagnosis of AML or MDS who are deemed fit for allo-SCT with one of the following disease characteristics: AML * Patients in 1s...
Vyxeos is a liposome injection being studied for use in acute myeloid leukemia (AML) and relapsed or refractory pediatric AML. It is also being evaluated in high-risk myelodysplastic syndrome in the context of allogeneic stem cell transplantation. Vyxeos is an investigational small molecule therapy in clinical development.
Vyxeos is developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate Vyxeos in hematologic malignancies, including acute myeloid leukemia and relapsed pediatric AML.
Vyxeos is in Phase 2 clinical development for acute myeloid leukemia and high-risk myelodysplastic syndrome. A separate Phase 1 trial is evaluating Vyxeos in combination with clofarabine for relapsed or refractory pediatric AML. Vyxeos remains investigational and is not yet approved by regulatory authorities.
Vyxeos is being studied in two clinical trials. NCT04217278 is a Phase 2 trial in adults with AML and high-risk myelodysplastic syndrome undergoing allogeneic stem cell transplantation, enrolling 333 participants in the United Kingdom. NCT07156435 is a Phase 1 trial combining Vyxeos with clofarabine in pediatric patients with relapsed or refractory AML across multiple European countries.
Yes, Vyxeos is also known as Vyxeos 44 MG / 100 MG Liposome Injection and Vyxeos/ Liposome. These names refer to the same liposomal formulation of the drug. The 44 mg and 100 mg designations indicate the two active components in the liposome injection.
Vyxeos is a liposome injection containing two chemotherapy agents, daunorubicin and cytarabine, in a synergistic 1:5 molar ratio. The liposomal formulation is designed to deliver both drugs to leukemia cells. Vyxeos is being studied in acute myeloid leukemia and related hematologic conditions.