CPX-351 (liposomal daunorubicin-cytarabine)
The two old chemotherapy drugs packed together into tiny fat bubbles at a fixed ratio, which doubled five-year survival in older adults with high-risk AML.
Fixed 5:1 molar ratio of cytarabine to daunorubicin in liposomes that persist in marrow. Study 301 (n=309, age 60-75, therapy-related or MDS-related AML): median OS 9.56 vs 5.95 months (HR 0.69), 5-year OS 18% vs 8%; benefit concentrated in patients bridged to transplant. Approved 2017 (adults) and 2021 (paediatric). Being tested in younger high-risk patients and MDS.
1.Liposomes circulate for days and accumulate in bone marrow
- Route
- IV over 90 minutes
- Schedule
- Induction days 1, 3, 5 (daunorubicin 44 mg/m² + cytarabine 100 mg/m² per dose); second induction days 1, 3; consolidation at reduced dose
- Monitoring
- Counts, cardiac function; do not substitute for conventional 7+3 dosing
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Almost always given inpatient during AML induction, so paid within the Part A stay.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- JazzCares
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Untreated therapy-related AML or AML with myelodysplasia-related changes
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA552 · SMC advice: CPX-351 (liposomal daunorubicin-cytarabine). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 3 Aug 2017ApprovalUS
Adults
- 30 Mar 2021Label changeUS
Paediatric expansion
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, adults |
| US | 2021 | Paediatric patients ≥1 year |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Prolonged cytopenias Longer neutrophil and platelet recovery than 7+3 | — | — |
| Haemorrhage Study 301, any grade | 74% | — |
| Febrile neutropenia | 68% | — |
| Cardiotoxicity Cumulative anthracycline exposure counts | — | — |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"CPX-351" OR ABSTRACT:"CPX-351" OR TITLE:"liposomal daunorubicin-cytarabine" OR ABSTRACT:"liposomal daunorubicin-cytarabine" OR TITLE:"Vyxeos" OR ABSTRACT:"Vyxeos") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about CPX-351 (liposomal daunorubicin-cytarabine), not a curated reading list.
Pages like this
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Shares CPX-351 Study 301, Cytotoxic chemotherapy, Acute myeloid leukaemia.
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- PersonEmil J Freireich