Jazz Pharmaceuticals to Highlight Hematology Research at ASH 2017 Annual Meeting
Nineteen abstracts accepted for three Jazz hematology/oncology products
DUBLIN, Nov. 1, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that thirteen abstracts spanning the company's hematology/oncology portfolio will be presented at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta from December 9-12, with an additional six abstracts accepted for online publication only in ASH's weekly medical journal Blood Online.
"The breadth of data presented at ASH reflects our commitment to addressing the clinical needs of patients with blood cancers and with complications of stem cell transplantation by advancing the science behind Vyxeos, Defitelio and Erwinaze," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "Jazz continues to expand its hematology/oncology portfolio and we are grateful to the patients and health care professionals who participate in our clinical trials."
Highlights at the American Society of Hematology meeting will include:
- Post-hoc efficacy and safety analyses, including a poster focused on the rate of adverse events, from the Phase 3 trial of Vyxeos™ (daunorubicin and cytarabine) liposome for injection, also known as CPX-351
- An oral presentation from an investigator-initiated Phase 2 trial of Vyxeos that analyzed remission rates in a group of newly diagnosed elderly acute myeloid leukemia (AML) patients at high risk of mortality
- A post-hoc analysis of the efficacy and safety of Vyxeos in patients with Refractory Anemia with Excess of Blasts in Transformation (RAEB-t) from the Phase 3 trial
- Post-hoc analyses from clinical trials and an expanded access program for Defitelio® (defibrotide sodium)
A full list of Jazz-supported oral and poster presentations covering Vyxeos, Defitelio and Erwinaze® (asparaginase Erwinia chrysanthemi) follows below:
| Vyxeos™ (daunorubicin and cytarabine) liposome for injection |
||
| Presentation Title |
Author |
Date / Time / Session/ |
| CPX-351 Exposure-Response Based on |
Banerjee et al. |
December 9 5:30-7:30 p.m. |
| Rates of Adverse Events Per Patient-Year |
Medeiros et al. |
December 9 5:30-7:30 p.m. |
| Subanalysis of Patients with Secondary |
Lin et al. |
December 9 5:30-7:30 p.m. |
| Multivariate Efficacy Analysis of a |
Uy et al. |
December 10 6:00-8:00 p.m. |
| Efficacy and Safety of CPX-351 Versus |
Lancet et al. |
December 10 6:00-8:00 p.m. |
| Cost-effectiveness of CPX-351 versus 7+3 |
Kansal et al. |
December 11 6:00-8:00 p.m. |
| CPX-351 Population Pharmacokinetics in |
Wang et al. |
Abstract 5064 |
| Budget Impact Analysis of CPX-351 in the |
Jenson et al. |
Abstract 5615 |
| Additionally, the following Jazz-supported Investigator-Initiated Research presentations focusing on Vyxeos will be presented at ASH: |
||
| Presentation Title |
Author |
Date / Time / Session/ |
| Randomized Study of CPX-351 for |
Walter et al. |
December 9 5:30-7:30 p.m. |
| Phase II Study of CPX-351 |
Borthakur et al. |
December 11 6:15-7:45 p.m. |
| Defitelio® (defibrotide sodium) |
||
| Presentation Title |
Author |
Date / Time / Session/ |
| Efficacy and Safety of Defibrotide in |
Kernan et al. |
December 9 5:30-7:30 p.m. |
| Pooled Analysis of Day +100 Survival for |
Richardson et al. |
December 9 5:30-7:30 p.m. |
| Final Analysis of Day +100 Survival by |
Richardson et al. |
December 10 6:00-8:00 p.m. |
| Adults Receiving Defibrotide for the |
Richardson et al. |
December 10 6:00-8:00 p.m. |
| Treatment of Hepatic Veno-Occlusive |
Grupp et al. |
December 11 6:00-8:00 p.m. |
| Timing of Defibrotide Initiation in Patients |
Del Pino et al. |
Abstract 5461 |
| Timing of Diagnosis and Severity of Veno- |
Del Pino et al. |
Abstract 5462 |
| Pooled Analysis of Defibrotide Studies in |
Richardson et al. |
Abstract 5467 |
| Erwinaze® (asparaginase Erwinia chrysanthemi) |
||
| Presentation Title |
Author |
Presentation Number/ Date / Time |
| Use of Premedication Prior to |
Bernard et al. |
Abstract 5574 |
About Vyxeos™
Vyxeos™ (daunorubicin and cytarabine) is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion. In the U.S., Vyxeos received FDA marketing approval on August 3, 2017 for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Due to different dosage recommendations, Vyxeos should not be substituted with other daunorubicin and/or cytarabine- containing products. Vyxeos can cause allergic reactions, including anaphylaxis and should not be given to patients who are allergic to Vyxeos or any of its ingredients. Vyxeos may cause heart-related side effects as well as a severe decrease in blood cells which can result in serious infection or bleeding and possibly lead to death. The most common side effects with Vyxeos are 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 before prescribing: http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf
About Defitelio®
In the U.S., Defitelio® (defibrotide sodium) received FDA marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).
Defitelio is contraindicated in patients currently taking anticoagulants or fibrinolytics and in patients who are allergic to Defitelio or any of its ingredients. Defitelio may increase the risk of bleeding and should be withheld or stopped if significant bleeding occurs. Patients should be monitored for allergic reactions, especially if there is a history of previous exposure to Defitelio. The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.
Please see full Prescribing Information for Defitelio before prescribing: http://pp.jazzpharma.com/pi/defitelio.en.USPI.pdf
About Erwinaze®
Erwinaze® (asparaginase Erwinia chrysanthemi) is currently approved in the U.S. for administration via intramuscular injection or via intravenous infusion in conjunction with chemotherapy. It is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase. Erwinaze is derived from the bacterium Erwinia chrysanthemi and is therefore immunologically distinct from E. coli-derived asparaginase and suitable for patients with hypersensitivity to E. coli-derived treatments.
Erwinaze is contraindicated in patients who have had serious allergic reactions to Erwinaze, or had serious swelling of the pancreas, serious blood clots, or serious bleeding with past L-asparaginase treatment. Erwinaze should be discontinued if any of the following occur: serious allergic reactions, including a feeling of tightness in the throat, unusual swelling/redness in the throat and/or tongue, or trouble bleeding; or severe inflammation of the pancreas. Glucose intolerance has been reported, which in some cases may be irreversible. If blood clots of bleeding occur, discontinue Erwinaze until symptoms resolve. The most common side effects of Erwinaze are allergic reactions, too much sugar in the blood, fever, swelling of the pancreas, local reactions (swelling, rash, etc. where the needle entered the skin), vomiting, nausea, blood clots, liver problems, stomach pain/discomfort, and diarrhea.
Please see full Prescribing Information for Erwinaze before prescribing: https://www.jazzpharma.com/wp-content/uploads/2016/01/erwinaze-en-PI.pdf
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos™ (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For country-specific product labels, please visit www.jazzpharma.com/products. For more information about Jazz, please visit www.jazzpharmaceuticals.com.
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