CPX-351
Trials 45
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-11-03 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Data at 2022 ASH Meeting Showcasing Commitment to Advancing Oncology Research jazzpharma.com ↗
Preliminary results suggest the combination of Vyxeos + MID is feasible with a manageable safety profile and promising remission rates in adults with newly diagnosed, FLT3 -mutated AML. |
| 2021-07-07 | Jazz Pharmaceuticals | Regulatory Health Canada Approves Vyxeos®, the First Chemotherapy Advance in over 40 years for Adults with High-risk Acute Myeloid Leukemia (AML) jazzpharma.com ↗
DUBLIN , July 7, 2021 /CNW/ - Jazz Pharmaceuticals plc (NASDAQ: JAZZ) today announced the Health Canada approval and availability of Vyxeos ® (daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). |
| 2021-03-30 | Jazz Pharmaceuticals | Regulatory 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 ↗
With the expansion of the Vyxeos label to include the pediatric population, Jazz demonstrates our continued commitment to broadening our cancer research and focusing on the people for whom we can have the greatest impact. |
| 2018-08-27 | Jazz Pharmaceuticals | Regulatory Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia jazzpharma.com ↗
DUBLIN , Aug. 27, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission approved Vyxeos ® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). |
| 2018-08-03 | Jazz Pharmaceuticals | Regulatory CMS Grants New Technology Add-On Payment to Vyxeos® (daunorubicin and cytarabine) Liposome for Injection jazzpharma.com ↗
The Vyxeos NTAP will support Medicare beneficiaries' access to Vyxeos when they are treated in certain inpatient hospital settings. |
| 2018-07-19 | Jazz Pharmaceuticals | Results Journal of Clinical Oncology publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos® (daunorubicin and cytarabine) Liposome for Injection jazzpharma.com ↗
The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. |
| 2018-06-29 | Jazz Pharmaceuticals | Regulatory Vyxeos™ Receives Positive CHMP Opinion for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation of Vyxeos™ |
| 2017-08-03 | Jazz Pharmaceuticals | Regulatory 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 ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer. |
| 2017-05-31 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status jazzpharma.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for VYXEOS™ |
| 2017-04-03 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Completes Rolling Submission of New Drug Application for Vyxeos™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia jazzpharma.com ↗
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion on March 31, 2017 of a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) |
| 2016-10-03 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Initiates Rolling NDA Submission for Vyxeos (CPX-351) Expects to Complete NDA Submission by Early 2017 jazzpharma.com ↗ |
All press releases naming this drug 17 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CPX-351 | “We aimed to evaluate the safety and preliminary activity of lower doses of CPX-351, a liposomal encapsulation of cytarabine and daunorubicin, in a single-centre, phase 1/2...” PMID 37946611 ↗ Nov 202347“This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with...” NCT04526288 ↗ “This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia” NCT02286726 ↗ “A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML).” NCT02642965 ↗ “This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia” NCT04269213 ↗ “This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia” NCT03904251 ↗ “Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.” NCT04195945 ↗ “CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer” NCT04293562 ↗ “Induction 1:CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3,5” NCT05260528 ↗ “The liposomal formulation of Vyxeos®/CPX-351 may be a suitable replacement for DNX” NCT07156435 ↗ “Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5” NCT04493164 ↗ |
| Known as | liposomal cytarabine-daunorubicin | “This phase 2 clinical trial studies how well CPX-351 (liposomal cytarabine-daunorubicin) works in treating patients with relapsed or refractory acute myeloid leukemia or...” NCT02019069 ↗ |
| Known as | liposome-encapsulated daunorubicin-cytarabine | “PRIMARY OBJECTIVES: I. To determine the phase II dose of the combination liposome-encapsulated daunorubicin-cytarabine (CPX-351) plus gemtuzumab ozogamicin (GO) by means of...” NCT03904251 ↗ |
| Known as | NSC# 775341 | “A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML).” NCT02642965 ↗ |
| Known as | VYXEOS | “CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio.” PMID 36289532 ↗ Oct 20223“CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome” NCT03572764 ↗ “The liposomal formulation of Vyxeos®/CPX-351 may be a suitable replacement for DNX” NCT07156435 ↗ “EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML” NCT02533115 ↗ |
| Known as | Vyxeos liposomal | “CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio.” PMID 36289532 ↗ Oct 2022 |
| Modality | Other / unclassified | “CPX-351 is a liposomal formulation of cytarabine:daunorubicin designed to deliver synergistic drug ratios to leukemia cells.” PMID 24687088 ↗ Mar 2014 |
| Route | Intravenous | “by 90-minute IV infusion” NCT00822094 ↗ |