DUBLIN, May 20, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (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
Presentation Title | Author | Poster Number / Abstract Link |
Phase 1/2 Study of Lurbinectedin in Combination with Irinotecan in Patients with Endometrial Carcinoma | Sanchez-Simon I, et al. | Poster Number: 5586
|
Treatment Patterns of Patients with Small Cell Lung Cancer in Second and Third-Line Therapy Settings | Prince P, et al. | Publication only |
Overall Survival of Small Cell Lung Cancer Patients Initiating Anti-Cancer Treatment | Estrin A, et al. | Publication only |
JZP351 (formerly known as CPX-351) Poster Presentation
Presentation Title | Author | Poster Number / Abstract Link |
Preliminary Results of V-FAST, a Phase 1B Master Trial to Investigate CPX-351 Combined with Targeted Agents in NewlyDiagnosed AML | Pullarkat V,et al. | Poster Number: 7026 |
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
Presentation Title | Author | Abstract Code / Abstract Link |
Preliminary Results of V-FAST, a Phase 1B Master Trial to Investigate CPX-351 Combined with Targeted Agents in Newly DiagnosedAML | Pullarkat V, et al. | Poster Number: EP442
|
Rapid Genomic Profiling of AML Patients with Myelodysplasia-related CytogeneticAberrations (investigator sponsored trial) | Dolnik A, et al. | Poster Number: EP402 |
Pilot Study of CPX-351 in Adults withRelapsed/Refractory Acute Lymphoblastic Leukemia (investigator sponsored trial) | Shah BD,et al. | Publication only |
Defibrotide Sodium Poster Presentations
Presentation Title | Author | Abstract Code / Abstract Link |
Incidence of Veno-Occlusive Disease/Sinusoidal ObstructionSyndrome (VOD/SOS) After Hematopoietic Cell Transplantation (HCT) in England Based on HealthcareResource Group Codes and HospitalEpisode Statistics© Data | Angus J, etal. | Poster Number: EP1258
|
EBMT Pass Registry Outcomes of Defibrotide-Treated Patients by Timing of Onset of VOD/SOS After HCT | Mohty M, et al. | Poster Number: EP1238 |
About Vyxeos®/Vyxeos® Liposomal (daunorubicin and cytarabine), also known as JZP 351Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor.
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 LIPOSOMALWARNING: 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:
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) Disclaimer: All information about Zepzelca is intended for a U.S.-audience only.Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.2
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)In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated 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) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the prevention of VOD.
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. (http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002393/human_med_001646.jsp)
The full Summary of Product Characteristics of Defitelio in Europe is available here.
Important Safety Information for DefitelioDefitelio should not be given to patients who are:
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 plcJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Caution Concerning Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to potentially addressing patient needs with our oncology portfolio and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc'sSecurities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2020 and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Contacts:
Media:Jacqueline KirbyVice President, Corporate Affairs Jazz Pharmaceuticals plcCorporateAffairsMediaInfo@jazzpharma.comIreland, +353 1 697 2141U.S. +1 215 867 4910
Investors:Andrea N. Flynn, Ph.D.Vice President, Head, Investor RelationsJazz Pharmaceuticals plcinvestorinfo@jazzpharma.com Ireland, +353 1 634 3211
References:
1 Vyxeos (daunorubicin and cytarabine) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2 ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
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SOURCE Jazz Pharmaceuticals plc