Investor Center
Investor Center

RSS Content

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/
Presentation Number/ Location

CPX-351 Exposure-Response Based on
Cumulative Dose of Cytarabine and
Daunorubicin in Patients with Newly
Diagnosed, Treatment-related Acute
Myeloid Leukemia (AML) or AML with
Myelodysplasia-related Changes

Banerjee et al.

December 9  5:30-7:30 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding Transplantation: Poster I
Poster Presentation 1360
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Rates of Adverse Events Per Patient-Year
in a Randomized, Phase 3 Study of CPX-
351 Versus 7+3 in Older Adults with Newly
Diagnosed, Treatment-related Acute
Myeloid Leukemia (AML) or AML with
Myelodysplasia-related Changes

Medeiros et al.

December 9  5:30-7:30 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding
Transplantation: Poster I
Poster Presentation 1366
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Subanalysis of Patients with Secondary
Acute Myeloid Leukemia (sAML) with
Refractory Anemia with Excess of Blasts in
Transformation (RAEB-t) Enrolled in a
Phase 3 Study of CPX-351 versus
Conventional 7+3 Cytarabine and
Daunorubicin

Lin et al.

December 9  5:30-7:30 p.m.
Session 637. Myelodysplastic
Syndromes—Clinical Studies:
Poster I
Poster Presentation 1698
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Multivariate Efficacy Analysis of a
Randomized, Phase 3 Study of CPX-351
Versus 7+3 in Older Adults with
Treatment-related Acute Myeloid Leukemia
(AML) or AML with Myelodysplasia-related
Changes

Uy et al.

December 10 6:00-8:00 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding Transplantation: Poster II
Poster Presentation 2647
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Efficacy and Safety of CPX-351 Versus
7+3 in Older Adults with Secondary Acute
Myeloid Leukemia: Combined Subgroup
Analysis of Phase 2 and Phase 3 Studies

Lancet et al.

December 10 6:00-8:00 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding Transplantation: Poster II
Poster Presentation 2657
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Cost-effectiveness of CPX-351 versus 7+3
Regimen in the Treatment of Treatment-
related Acute Myeloid Leukemia (tAML) or
AML with Myelodysplasia-related Changes
(MRC)

Kansal et al.

December 11 6:00-8:00 p.m.
Session 902. Health Services
Research—Malignant Conditions:
Poster III
Poster Presentation 4674
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

CPX-351 Population Pharmacokinetics in
Patients with Hematologic Malignancies

Wang et al.

Abstract 5064
Online only in Blood

Budget Impact Analysis of CPX-351 in the
Treatment of Patients with Treatment-
related Acute Myeloid Leukemia (tAML) or
AML with Myelodysplasia-related Changes
(MRC) from a US Payer Perspective

Jenson et al.

Abstract 5615
Online only in Blood



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
Medically Less-Fit Adults with Newly
Diagnosed Acute Myeloid Leukemia or
Other High-Grade Myeloid Neoplasm

Walter et al.

December 9  5:30-7:30 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding Transplantation: Poster I
Poster Presentation 1346
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Phase II Study of CPX-351
(Cytarabine:Daunorubicin) Liposome
Injection in Patients with Newly Diagnosed
AML at High Risk for Induction Mortality

Borthakur et al.

December 11 6:15-7:45 p.m.
Session 616. Acute Myeloid
Leukemia: Novel Therapy, excluding Transplantation: Novel Therapies for
Elderly Patients with AML
Oral Presentation 892
Georgia World Congress Center,
Bldg B, Lvl 5, Murphy BR 1-2



Defitelio® (defibrotide sodium)


Presentation Title

Author

Date / Time / Session/
Presentation Number/ Location

Efficacy and Safety of Defibrotide in
Pediatric Patients with Veno-Occlusive
Disease/Sinusoidal Obstruction Syndrome
(VOD/SOS) After Hematopoietic Stem Cell
Transplantation (HSCT): Final Results
from the Expanded-Access Program

Kernan et al.

December 9  5:30-7:30 p.m.
Session 721. Clinical Allogeneic
Transplantation: Conditioning
Regimens, Engraftment, and Acute
Transplant Toxicities: Poster I
Poster Presentation 1948
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Pooled Analysis of Day +100 Survival for
Defibrotide-Treated Patients With Hepatic
Veno-Occlusive Disease/Sinusoidal
Obstruction Syndrome (VOD/SOS) and
Ventilator or Dialysis Dependence
Following Hematopoietic Stem Cell
Transplantation (HSCT)

Richardson et al.

December 9  5:30-7:30 p.m.
Session 721. Clinical Allogeneic
Transplantation: Conditioning
Regimens, Engraftment, and Acute
Transplant Toxicities: Poster I
Poster Presentation 1946
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Final Analysis of Day +100 Survival by
Prior Hematopoietic Stem Cell Transplant
Type From an Expanded Access Study of
Defibrotide for Hepatic Veno-Occlusive
Disease/Sinusoidal Obstruction Syndrome

Richardson et al.

December 10 6:00-8:00 p.m.
Session 721. Clinical Allogeneic Transplantation: Conditioning
Regimens, Engraftment, and Acute
Transplant Toxicities: Poster II
Poster Presentation 3224
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Adults Receiving Defibrotide for the
Treatment of Hepatic Veno-Occlusive
Disease/Sinusoidal Obstruction Syndrome
(VOD/SOS) After Hematopoietic Stem Cell
Transplantation (HSCT): Final Results
from the Expanded-Access Program

Richardson et al.

December 10 6:00-8:00 p.m.
Session 721. Clinical Allogeneic
Transplantation: Conditioning
Regimens, Engraftment, and Acute
Transplant Toxicities: Poster II
Poster Presentation 3225
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Treatment of Hepatic Veno-Occlusive
Disease/Sinusoidal Obstruction Syndrome
(VOD/SOS) Post-Hematopoietic Stem Cell
Transplantation (HSCT) in Patients With
Neuroblastoma: Final Data From the
Defibrotide Expanded-Access Program

Grupp et al.

December 11 6:00-8:00 p.m.
Session 731. Clinical Autologous Transplantation: Results: Poster III
Poster Presentation 4549
Georgia World Congress Center,
Bldg A, Lvl 1, Hall A2

Timing of Defibrotide Initiation in Patients
with Veno-Occlusive Disease/Sinusoidal
Obstruction Syndrome (VOD/SOS) and
Multi-Organ Dysfunction (MOD) After
Hematopoietic Stem Cell Transplantation
(HSCT): Results from a Retrospective
Chart Review

Del Pino et al.

Abstract 5461
Online only in Blood

Timing of Diagnosis and Severity of Veno-
Occlusive Disease/Sinusoidal Obstruction
Syndrome (VOD/SOS) at Diagnosis After
Hematopoietic Stem Cell Transplantation:
Results from a Retrospective Chart Review

Del Pino et al.

Abstract 5462
Online only in Blood

Pooled Analysis of Defibrotide Studies in
the Treatment of Veno-occlusive
Disease/Sinusoidal Obstruction Syndrome
(VOD/SOS) after Hematopoietic Stem Cell
Transplantation (HSCT) or Chemotherapy
Without HSCT

Richardson et al.

Abstract 5467
Online only in Blood



Erwinaze®  (asparaginase Erwinia chrysanthemi)


Presentation Title

Author

Presentation Number/ Date / Time
/ Location

Use of Premedication Prior to
Asparaginase (ASNase) Administration in
Pediatric Acute Lymphoblastic Leukemia
(ALL): Effect on Treatment Completion
Rate

Bernard et al.

Abstract 5574
Online only in Blood

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.

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

 

View original content with multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-highlight-hematology-research-at-ash-2017-annual-meeting-300547361.html

SOURCE Jazz Pharmaceuticals plc

Media Contact: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland +353 1 697 2141, U.S. +1 215 867 4910; Investor Contact: Kathee Littrell, Vice President, Investor Relations, Ireland +353 1 634 7887, U.S. +1 650 496 2717