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
|May 31, 2017||Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status|
|Apr 3, 2017||Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia|
|Oct 3, 2016||Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017|
|May 19, 2016||Celator Pharmaceuticals Announces Vyxeos Granted Breakthrough Therapy Designation|
|Mar 14, 2016||Celator 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, 2012||Celator Pharmaceuticals Announces Data on the Effects of CPX-351 in High Risk AML Presented at the ASH Annual Meeting|
|Jun 5, 2012||Celator Pharmaceuticals Announces Presentations of Positive Survival Analyses from CPX-351 Studies at ASCO Annual Meeting|
|Dec 12, 2011||Celator 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, 2010||Celator Pharmaceuticals Presents Positive Data from Phase 2 Study of CPX-351 at the American Society of Hematology Annual Meeting|
|Jun 7, 2010||Celator Pharmaceuticals Announces Data on Remissions With CPX-351 Following Induction Failure|
|May 3, 2010||Celator Pharmaceuticals Announces Positive Data From Phase 2 Study of CPX-351 in Acute Myeloid Leukemia|
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