Jazz to Present New Data at ASCO and EHA 2021 Meetings Showcasing Clinical Advances Across Hematology and Oncology Portfolio
DUBLIN, May 20, 2021 /PRNewswire/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that it and its investigator sponsors will present four new abstracts at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4 – June 8, 2021 and five abstracts at the virtual 26th Annual Congress of the European Hematology Association (EHA2021) from June 9 –16, 2021. Research findings to be presented include new data on Zepzelca® (lurbinectedin), Vyxeos®/Vyxeos® Liposomal (daunorubicin and cytarabine), also known as JZP351 (formerly known as CPX-351), and Defitelio® (defibrotide sodium). "The unmet needs of patients facing unique challenges and difficult odds drive our research and development objectives, and it's critical for us to continue enhancing our understanding of our existing therapies so that the greatest number of patients can benefit from our innovative medicines," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals. "We are excited to build upon our growing oncology portfolio and make meaningful strides for more people living with rare or complex hematologic and oncologic diseases." Highlights from Jazz and its investigational sponsors at the congresses will include:
All ASCO virtual poster presentations and poster discussion presentations will be available on-demand to registered participants for 180 days beginning June 4, 2021. The Jazz-supported and investigational sponsor presentations and publications covering lurbinectedin and JZP351 (formerly known as CPX-351) at the ASCO Annual Meeting are: Lurbinectedin Presentations
JZP351 (formerly known as CPX-351) Poster Presentation
The poster presentations and publications covering JZP351 (formerly known as CPX-351) and defibrotide sodium at EHA2021 virtual congress are: JZP351 (formerly known as CPX-351) Presentations
Defibrotide Sodium Poster Presentations
About Vyxeos®/Vyxeos® Liposomal (daunorubicin and cytarabine), also known as JZP 351 In the U.S., Vyxeos is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.1 More information about Vyxeos in the United States, including Full Prescribing Information, BOXED Warning and Medication Guide, is available here. In Europe, Vyxeos Liposomal (daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Backed by a robust clinical development program including Phase 3 data, Vyxeos is currently approved in more than 30 countries, and Jazz continues to work with regulatory authorities worldwide to bring this innovative therapy to appropriate patients. The full Summary of Product Characteristics of Vyxeos Liposomal in Europe is available here. Important Safety Information for VYXEOS/VYXEOS LIPOSOMAL 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:
VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
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. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568. About Zepzelca® (lurbinectedin) Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use. Important Safety Information for ZEPZELCA Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works. What should I avoid while using ZEPZELCA? Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA. ZEPZELCA can cause serious side effects, including:
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA. The most common side effects of ZEPZELCA include:
These are not all of the possible side effects of ZEPZELCA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568. More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here. ZEPZELCA is a trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license. About Defitelio® (defibrotide sodium) Please see full Prescribing Information for Defitelio in the United States. In Europe, defibrotide is marketed under the name Defitelio® ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy. ▼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. The full Summary of Product Characteristics of Defitelio in Europe is available here. Important Safety Information for Defitelio
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. About Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements Contacts: Media: Investors: References: 1 Vyxeos (daunorubicin and cytarabine) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
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Company Codes: NASDAQ-NMS:JAZZ |