^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Vyxeos (cytarabine/daunorubicin liposomal formulation)

    i
    Other names: CPX-351, NS 87, JZP351, CPX351, CPX 351, JZP-351, JZP 351, NS87, NS-87
    Company:
    Jazz, Nippon Shinyaku
    Drug class:
    DNA synthesis inhibitor, Topoisomerase II inhibitor, DNA polymerase inhibitor
    Related drugs:
    5d
    Adverse karyotype amplifies risk in secondary acute myeloid leukemia (AML) and AML with myelodysplasia-related changes. (PubMed, Hematology)
    sAML/AML-MRC with an adverse karyotype had a dismal outcome. These findings provide a benchmark for risk stratification in the pre- CPX-351 era.
    Retrospective data • Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    13d
    CPX-351 Selectively Benefits Patients with AML and Myelodysplasia-Related Mutations in the Pivotal Randomized Trial. (PubMed, Blood Adv)
    The OS benefit of CPX-351 observed in the trial was driven by AML-MR with no benefit of CPX-351 in TP53-AML, where the primary prognostic factor was allelic state. Clinical Trial Information: NCT01696084.
    Journal
    |
    TP53 (Tumor protein P53) • DDX41 (DEAD-Box Helicase 41)
    |
    TP53 mutation
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P1/2, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Vanflyta (quizartinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    NCI-2019-08946: CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, Roswell Park Cancer Institute | Suspended --> Active, not recruiting | N=46 --> 21 | Trial primary completion date: Jan 2027 --> Jun 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    MCC-21450: CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML (clinicaltrials.gov)
    P1, N=18, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Apr 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    CPX-351 and the Frontier of Nanoparticle-Based Therapeutics in Acute Myeloid Leukemia. (PubMed, Int J Mol Sci)
    Despite these gains, the absolute survival benefit remains modest, prolonged cytopenias are universal, and outcomes in TP53-mutated or younger adverse-risk patients are still poor, raising legitimate questions about cost-effectiveness and generalizability. Nonetheless, CPX-351 stands as the first clinically validated example of ratiometric nanomedicine in oncology, proving that reformulating established drugs can yield meaningful progress where novel agents have often failed.
    Review • Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    AAML1831: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov)
    P3, N=1186, Recruiting, Children's Oncology Group | Trial completion date: Sep 2027 --> Jun 2029 | Trial primary completion date: Sep 2027 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate) • dexrazoxane
    3ms
    VYSION: VYxeoS Liposomal Italian Observational Study iN the Real Practice (clinicaltrials.gov)
    P=N/A, N=113, Completed, Jazz Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Feb 2026 --> Oct 2025 | Trial primary completion date: Feb 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    NCI-2019-08946: CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old (clinicaltrials.gov)
    P2, N=46, Suspended, Roswell Park Cancer Institute | Recruiting --> Suspended
    Trial suspension
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    CPX-351 versus daunorubicin, cytarabine plus gemtuzumab ozogamicin in older adults with non-adverse risk AML: NCRI AML18. (PubMed, Blood)
    For patients entering the course-2 randomisation (n=107) survival was equivalent between standard versus intensified CPX doses (P=0.565).In this population of older patients without known adverse-risk cytogenetics, DAGO2 resulted in superior survival compared to CPX. CPX did not benefit those with MDS-related mutations over DAGO2.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
    |
    FLT3 mutation
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    NCI-2018-01812: Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)