Drugs / Vyxeos

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) VYXEOS — 2017-08-03 fda.gov ↗

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT05558124 Feb 2023 → Apr 2027 expected acute myeloid leukemia H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT05024552 Feb 2022 → Feb 2027 expected acute myeloid leukemia, FLT3 internal tandem duplication H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT03826992 Dec 2018 → Jan 2027 expected leukemia Children's Hospital Medical Center, Cincinnati Recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04049539 Jan 2021 → Dec 2026 expected acute myeloid leukemia Ohio State University Comprehensive Cancer Center Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT05599360 Aug 2022 → Sep 2028 expected acute myeloid leukemia Shaare Zedek Medical Center Active not recruiting No outcome recorded
Phase 2 NCT04425655 Aug 2020 → Jul 2022 acute myeloid leukemia University of California, San Diego Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04217278 Jan 2020 → May 2026 overdue acute myeloid leukemia, myelodysplastic syndrome University of Birmingham Active not recruiting No outcome recorded

Press releases naming this drug 16 releases

DateIssuerRelease
2023-03-08 Jazz Pharmaceuticals Jazz Pharmaceuticals Secures Eight Additional Provincial Reimbursements for Vyxeos® for Treatment of Adults with Newly Diagnosed Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes jazzpharma.com ↗
2021-07-07 Jazz Pharmaceuticals Health Canada Approves Vyxeos®, the First Chemotherapy Advance in over 40 years for Adults with High-risk Acute Myeloid Leukemia (AML) jazzpharma.com ↗
2021-03-30 Jazz Pharmaceuticals Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos® (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients jazzpharma.com ↗
2018-09-11 Jazz Pharmaceuticals Jazz Pharmaceuticals Announces an Informational Webcast for Investors Related to Vyxeos EU Launch jazzpharma.com ↗
2018-08-27 Jazz Pharmaceuticals Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia jazzpharma.com ↗
2018-08-03 Jazz Pharmaceuticals CMS Grants New Technology Add-On Payment to Vyxeos® (daunorubicin and cytarabine) Liposome for Injection jazzpharma.com ↗
2018-07-19 Jazz Pharmaceuticals Journal of Clinical Oncology publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos® (daunorubicin and cytarabine) Liposome for Injection jazzpharma.com ↗
2018-06-29 Jazz Pharmaceuticals Vyxeos™ Receives Positive CHMP Opinion for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia jazzpharma.com ↗
2018-02-08 Jazz Pharmaceuticals National Comprehensive Cancer Network® adds Jazz Pharmaceuticals' Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection to Clinical Practice Guidelines in Oncology jazzpharma.com ↗
2017-11-03 Jazz Pharmaceuticals Jazz Pharmaceuticals Submits Vyxeos™ Marketing Authorization Application to European Medicines Agency for Treatment of Certain Types of High-Risk Acute Myeloid Leukemia jazzpharma.com ↗
2017-08-03 Jazz Pharmaceuticals Jazz Pharmaceuticals Announces Webcast for Vyxeos Investor Update jazzpharma.com ↗
2017-08-03 Jazz Pharmaceuticals Jazz Pharmaceuticals Announces FDA Approval of Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection for the Treatment of Adults with Newly-Diagnosed Therapy-Related Acute Myeloid Leukemia (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC) jazzpharma.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Vyxeos “Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome.” NCT04049539 ↗
6

NCT04217278 ↗

NCT03826992 ↗

NCT04425655 ↗

NCT05599360 ↗

NCT05558124 ↗

NCT05024552 ↗

Known as CPX-351 “Vyxeos (CPX-351, cytarabine and daunorubicin liposome)” NCT03826992 ↗
Modality Other / unclassified “Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome.” NCT04049539 ↗
Route Intravenous “administered via intravenous infusion” NCT03826992 ↗