Jazz Pharmaceuticals to Highlight Hematology Research at ASH 2018 Annual Meeting
"We look forward to showcasing our commitment to the hematology/oncology community at ASH by advancing the science and addressing the clinical needs of patients with blood cancers and with complications of stem cell transplantation," said
Results from a post-hoc analysis from the pivotal Phase 3 randomized trial of Vyxeos® (daunorubicin and cytarabine) liposome for injection, also known as the molecule name CPX-351, in a subgroup of older patients with newly diagnosed high risk (secondary) AML with myelodysplasia-related changes (AML-MRC) that evaluated the efficacy of Vyxeos compared to conventional 7+3 chemotherapy on overall survival and remission rates as well as the safety profile in older adults with AML-MRC. Additionally, data will be presented from an exploratory analysis which evaluated the impact of hematopoietic cell transplantation (HCT) on survival in patients treated with Vyxeos compared to 7+3 in the Phase 3 trial.
Vyxeos abstracts include:
- Efficacy and Safety of CPX-351 versus 7+3 in a Subgroup of Older Patients with Newly Diagnosed Acute Myeloid Leukemia with Myelodysplasia-Related Changes (AML-MRC) Enrolled in a Phase 3 Study [Abstract #1425;
Saturday, December 1 ,6:15 PM –8:15 PM PST ] - Population Pharmacokinetic (PK)/Pharmacodynamic (PD) Modeling of Myelosuppression in Patients with Hematologic Malignancies for CPX-351 and Standard-of-Care 7+3 Therapy [Abstract #4037;
Monday, December 3 ,6:00 PM –8:00 PM PST ] - The Impact of Hematopoietic Cell Transplantation on Survival: An Exploratory Analysis of a Phase 3 Study of CPX-351 versus 7+3 in Older Patients with Newly Diagnosed, High-Risk/Secondary AML [Abstract #2706;
Sunday, December 2 ,6:00 PM –8:00 PM PST ] - Final Safety and Efficacy Results from the CPX-351 Early Access Program (EAP) for Older Patients with High-Risk/Secondary Acute Myeloid Leukemia (sAML) [Abstract #1434;
Saturday, December 1 ,6:15 PM –8:15 PM PST ] - Impact of Post–Hematopoietic Cell Transplant (HCT) Survival on Cost-effectiveness of CPX-351 versus 7+3 in the Treatment of Therapy-Related AML or AML-MRC in
the United States (online only) - A Phase I/Pilot Study of CPX-351 [Daunorubicin and Cytarabine Liposome for Injection (Vyxeos®)] for Children, Adolescents and Young Adults with Recurrent or Refractory Acute Leukemia [Abstract #336;
Sunday, December 2 ,10:45 AM PST (oral presentation)]
In addition, data from an expanded access program and post-hoc analyses of clinical trials for Defitelio® (defibrotide sodium) will be presented, including an oral presentation of a pooled analysis of survival based on timing of initiation in adults with Veno-Occlusive Disease/ Sinusoidal Obstruction Syndrome (VOC/SOS) following hematopoietic stem cell transplant (HSCT).
Defitelio abstracts include:
- Incidence of Post-Hematopoietic Stem Cell Transplantation (HSCT) Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Without Hyperbilirubinemia at Diagnosis and Efficacy of Defibrotide in an Expanded-Access Program [Abstract #2080;
Saturday, December 1 ,6:15 PM –8:15 PM PST ] - A Pooled Analysis of Survival by Defibrotide Timing of Initiation in Adults with Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) Following Hematopoietic Stem Cell Transplant (HSCT) [Abstract #815;
Monday, December 3 ,3:45 PM PST (oral presentation)] - Cost-Effectiveness of Defibrotide for the Treatment of Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS) with Multi-Organ Dysfunction (MOD) Post-Hematopoietic Stem Cell Transplantation (HSCT) in
Canada [Abstract #4702;Monday, December 3 ,6:00 PM –8:00 PM PST ]
About Vyxeos®
Vyxeos® (daunorubicin and cytarabine) is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion, and is approved for the treatment of two types of secondary AML in adult patients, newly diagnosed therapy-related acute myeloid leukaemia (t-AML) and AML with myelodysplasia-related changes (AML-MRC). Vyxeos is the first product developed with the company's proprietary CombiPlex® platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received U.S.
Important Safety Information
Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.
Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.
Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.
Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:
- shortness of breath or trouble breathing
- swelling or fluid retention, especially in the feet, ankles or legs
- unusual tiredness
- Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
- trouble breathing
- severe itching
- skin rash or hives
- swelling of the face, lips, mouth, or tongue
Vyxeos contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders.
Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.
Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.
The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.
Please see full Prescribing Information for Vyxeos including BOXED Warning, and visit www.Vyxeos.com for additional information.
About Defitelio®
In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S.
In
*This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC. (https://www.ema.europa.eu/documents/product-information/defitelio-epar-product-information_en.pdf)
Important Safety Information
Defitelio should not be given to patients who are:
- Currently taking anticoagulants or fibrinolytics
- Allergic to Defitelio or any of its ingredients
Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.
Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately.
The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.
Please see full Prescribing Information for Defitelio and visit www.Defitelio.com for additional information.
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Media Contact: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland +353 1 697 2141, U.S. +1 215 867 4910 or Investor Contact: Kathee Littrell, Vice President, Investor Relations, Ireland +353 1 634 7887, U.S. +1 650 496 2717