Jazz Pharmaceuticals to Highlight Hematology Research at ASH 2017 Annual Meeting
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(TM)
(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(TM) (daunorubicin and cytarabine) liposome for injection
Presentation Title Author Date / Time / Session/
Presentation Number/ Location
--- --- -----------------------------
CPX-351 Exposure-Response Based on Banerjee et al. December 9 5:30-7:30 p.m.
Cumulative Dose of Cytarabine and Session 616. Acute Myeloid
Daunorubicin in Patients with Newly Leukemia: Novel Therapy, excluding Transplantation: Poster I
Diagnosed, Treatment-related Acute Poster Presentation 1360
Myeloid Leukemia (AML) or AML with Georgia World Congress Center,
Myelodysplasia-related Changes Bldg A, Lvl 1, Hall A2
------------------------------ ------------------------------ ----------------------
Rates of Adverse Events Per Patient-Year Medeiros et al. December 9 5:30-7:30 p.m.
in a Randomized, Phase 3 Study of CPX- Session 616. Acute Myeloid
351 Versus 7+3 in Older Adults with Newly Diagnosed, Treatment-related Acute Leukemia: Novel Therapy, excluding Transplantation: Poster I
Myeloid Leukemia (AML) or AML with Poster Presentation 1366
Myelodysplasia-related Changes Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Subanalysis of Patients with Secondary Lin et al. December 9 5:30-7:30 p.m.
Acute Myeloid Leukemia (sAML) with Session 637. Myelodysplastic
Refractory Anemia with Excess of Blasts in Syndromes-Clinical Studies:
Transformation (RAEB-t) Enrolled in a Poster I
Phase 3 Study of CPX-351 versus Poster Presentation 1698
Conventional 7+3 Cytarabine and Georgia World Congress Center,
Daunorubicin Bldg A, Lvl 1, Hall A2
------------ ------------ ----------------------
Multivariate Efficacy Analysis of a Uy et al. December 10 6:00-8:00 p.m.
Randomized, Phase 3 Study of CPX-351 Session 616. Acute Myeloid
Versus 7+3 in Older Adults with Leukemia: Novel Therapy, excluding Transplantation: Poster II
Treatment-related Acute Myeloid Leukemia Poster Presentation 2647
(AML) or AML with Myelodysplasia-related Georgia World Congress Center,
Changes Bldg A, Lvl 1, Hall A2
------- ------- ----------------------
Efficacy and Safety of CPX-351 Versus Lancet et al. December 10 6:00-8:00 p.m.
7+3 in Older Adults with Secondary Acute Session 616. Acute Myeloid
Myeloid Leukemia: Combined Subgroup Leukemia: Novel Therapy, excluding Transplantation: Poster II
Analysis of Phase 2 and Phase 3 Studies Poster Presentation 2657
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Cost-effectiveness of CPX-351 versus 7+3 Kansal et al. December 11 6:00-8:00 p.m.
Regimen in the Treatment of Treatment- Session 902. Health Services
related Acute Myeloid Leukemia (tAML) or Research-Malignant Conditions:
AML with Myelodysplasia-related Changes Poster III
(MRC) Poster Presentation 4674
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
CPX-351 Population Pharmacokinetics in Wang et al. Abstract 5064
Patients with Hematologic Malignancies Online only in Blood
-------------------------------------- -------------------------------------- --------------------
Budget Impact Analysis of CPX-351 in the Jenson et al. Abstract 5615
Treatment of Patients with Treatment- Online only in Blood
related Acute Myeloid Leukemia (tAML) or
AML with Myelodysplasia-related Changes
(MRC) from a US Payer Perspective
--------------------------------- ---
Additionally, the following Jazz-supported Investigator-Initiated Research presentations focusing on Vyxeos will be presented at ASH:
Presentation Title Author Date / Time / Session/
Presentation Number/ Location
--- --- -----------------------------
Randomized Study of CPX-351 for Walter et al. December 9 5:30-7:30 p.m.
Medically Less-Fit Adults with Newly Session 616. Acute Myeloid
Diagnosed Acute Myeloid Leukemia or Leukemia: Novel Therapy, excluding Transplantation: Poster I
Other High-Grade Myeloid Neoplasm Poster Presentation 1346
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Phase II Study of CPX-351 Borthakur et al. December 11 6:15-7:45 p.m.
(Cytarabine:Daunorubicin) Liposome Session 616. Acute Myeloid
Injection in Patients with Newly Diagnosed Leukemia: Novel Therapy, excluding Transplantation: Novel Therapies for
AML at High Risk for Induction Mortality Elderly Patients with AML
Oral Presentation 892
Georgia World Congress Center,
Bldg B, Lvl 5, Murphy BR 1-2
--- --- ----------------------------
Defitelio(R) (defibrotide sodium)
Presentation Title Author Date / Time / Session/
Presentation Number/ Location
--- --- -----------------------------
Efficacy and Safety of Defibrotide in Kernan et al. December 9 5:30-7:30 p.m.
Pediatric Patients with Veno-Occlusive Session 721. Clinical Allogeneic
Disease/Sinusoidal Obstruction Syndrome Transplantation: Conditioning
(VOD/SOS) After Hematopoietic Stem Cell Regimens, Engraftment, and Acute
Transplantation (HSCT): Final Results Transplant Toxicities: Poster I
from the Expanded-Access Program Poster Presentation 1948
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Pooled Analysis of Day +100 Survival for Richardson et al. December 9 5:30-7:30 p.m.
Defibrotide-Treated Patients With Hepatic Session 721. Clinical Allogeneic
Veno-Occlusive Disease/Sinusoidal Transplantation: Conditioning
Obstruction Syndrome (VOD/SOS) and Regimens, Engraftment, and Acute
Ventilator or Dialysis Dependence Transplant Toxicities: Poster I
Following Hematopoietic Stem Cell Poster Presentation 1946
Transplantation (HSCT) Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Final Analysis of Day +100 Survival by Richardson et al. December 10 6:00-8:00 p.m.
Prior Hematopoietic Stem Cell Transplant Session 721. Clinical Allogeneic Transplantation: Conditioning Regimens,
Engraftment, and Acute
Type From an Expanded Access Study of Transplant Toxicities: Poster II
Defibrotide for Hepatic Veno-Occlusive Poster Presentation 3224
Disease/Sinusoidal Obstruction Syndrome Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Adults Receiving Defibrotide for the Richardson et al. December 10 6:00-8:00 p.m.
Treatment of Hepatic Veno-Occlusive Session 721. Clinical Allogeneic
Disease/Sinusoidal Obstruction Syndrome Transplantation: Conditioning
(VOD/SOS) After Hematopoietic Stem Cell Regimens, Engraftment, and Acute
Transplantation (HSCT): Final Results Transplant Toxicities: Poster II
from the Expanded-Access Program Poster Presentation 3225
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2
--- --- ----------------------
Treatment of Hepatic Veno-Occlusive Grupp et al. December 11 6:00-8:00 p.m.
Disease/Sinusoidal Obstruction Syndrome Session 731. Clinical Autologous Transplantation: Results: Poster III
(VOD/SOS) Post-Hematopoietic Stem Cell Poster Presentation 4549
Transplantation (HSCT) in Patients With Georgia World Congress Center,
Neuroblastoma: Final Data From the Bldg A, Lvl 1, Hall A2
Defibrotide Expanded-Access Program
----------------------------------- ---
Timing of Defibrotide Initiation in Patients Del Pino et al. Abstract 5461
with Veno-Occlusive Disease/Sinusoidal Online only in Blood
Obstruction Syndrome (VOD/SOS) and
Multi-Organ Dysfunction (MOD) After
Hematopoietic Stem Cell Transplantation
(HSCT): Results from a Retrospective
Chart Review
------------ ---
Timing of Diagnosis and Severity of Veno- Del Pino et al. Abstract 5462
Occlusive Disease/Sinusoidal Obstruction Online only in Blood
Syndrome (VOD/SOS) at Diagnosis After
Hematopoietic Stem Cell Transplantation:
Results from a Retrospective Chart Review
----------------------------------------- ---
Pooled Analysis of Defibrotide Studies in Richardson et al. Abstract 5467
the Treatment of Veno-occlusive Online only in Blood
Disease/Sinusoidal Obstruction Syndrome
(VOD/SOS) after Hematopoietic Stem Cell
Transplantation (HSCT) or Chemotherapy
Without HSCT
------------ ---
Erwinaze(R) (asparaginase Erwinia chrysanthemi)
Presentation Title Author Presentation Number/ Date / Time
/ Location
--- --- ----------
Use of Premedication Prior to Bernard et al. Abstract 5574
Asparaginase (ASNase) Administration in Online only in Blood
Pediatric Acute Lymphoblastic Leukemia
(ALL): Effect on Treatment Completion
Rate
---- ---
About Vyxeos(TM)
Vyxeos(TM) (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(TM) (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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