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Vyxeos Approval Status

Vyxeos (cytarabine and daunorubicin liposome injection) is an investigational nano-scale liposome co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio in development for the treatment of acute myeloid leukemia.

Development Status and FDA Approval Process for Vyxeos

DateArticle
Oct  3, 2016Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017
May 19, 2016Celator Pharmaceuticals Announces Vyxeos Granted Breakthrough Therapy Designation
Mar 14, 2016Celator Announces Phase 3 Trial for Vyxeos™ (CPX-351) in Patients with High-Risk Acute Myeloid Leukemia Demonstrates Statistically Significant Improvement in Overall Survival
Dec 11, 2012Celator Pharmaceuticals Announces Data on the Effects of CPX-351 in High Risk AML Presented at the ASH Annual Meeting
Jun  5, 2012Celator Pharmaceuticals Announces Presentations of Positive Survival Analyses from CPX-351 Studies at ASCO Annual Meeting
Dec 12, 2011Celator Pharmaceuticals and the Leukemia & Lymphoma Society Announce Positive Data from Phase 2b Study of CPX-351 at the American Society of Hematology Annual Meeting
Dec  7, 2010Celator Pharmaceuticals Presents Positive Data from Phase 2 Study of CPX-351 at the American Society of Hematology Annual Meeting
Jun  7, 2010Celator Pharmaceuticals Announces Data on Remissions With CPX-351 Following Induction Failure
May  3, 2010Celator Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia

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