New trial results
of investigational bispecific antibody zanidatamab
presented at SABCS in HER2+/HR+ metastatic breast cancer
Strong presence at ASH includes 11
presentations spanning Jazz's portfolio, advancing research into
difficult-to-treat blood cancers and diseases
Real-world data at NACLC reinforce clinical
impact of Zepzelca® (lurbinectedin) in small cell lung
cancer
DUBLIN, Nov. 30,
2023 /PRNewswire/ -- Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) today announced that the Company and its partners
will present two abstracts at the 2023 San Antonio Breast Cancer
Symposium (SABCS) from December 5-9;
11 abstracts at the 65th Annual American Society of Hematology
(ASH) Annual Meeting from December
9-12; and two abstracts at the International Association for
the Study of Lung Cancer (IASLC) 2023 North America Conference on
Lung Cancer (NACLC) from December
1-3. New data include updated findings from a Phase 2a trial
of the investigational HER2-targeted bispecific antibody
zanidatamab in combination with palbociclib and fulvestrant as a
chemotherapy-free option for HER2+/ HR+ metastatic breast cancer
(mBC).
"Following recent trial results showing the potential of
zanidatamab to treat HER2-expressing gastric and biliary tract
cancers at ASCO GI, ASCO and ESMO this year, we're excited to share
updated data at SABCS in HER2-amplified and hormone
receptor-positive metastatic breast cancer when zanidatamab is used
in combination to target the HER2, CDK4/6 and hormone receptor
pathways," said Rob Iannone, M.D.,
M.S.C.E., executive vice president, global head of research and
development of Jazz Pharmaceuticals. "SABCS will also feature data
from a trial of zanidatamab in neoadjuvant breast cancer.
Additionally, we look forward to sharing new data through numerous
presentations at ASH 2023 that underscore our commitment to
improving standards of care in blood cancer and other hematologic
diseases, as well as real-world findings at NACLC that provide
evidence of Zepzelca's safety in clinical practice for the
treatment of second-line small cell lung cancer."
Notable presentations at this year's SABCS, ASH and NACLC
meetings include:
- A SABCS oral presentation (late-breaking abstract) featuring
primary results from a Phase 2a study for a chemotherapy-free
option in heavily pretreated patients with HER2+/HR+ mBC treated
with the combination of zanidatamab plus palbociclib and
fulvestrant.
- An investigator-sponsored (MD Anderson Cancer Center) SABCS
poster presentation featuring results of a Phase 1 trial evaluating
neoadjuvant zanidatamab in patients with stage 1 node-negative
HER2+ breast cancer as a single-agent chemotherapy-free
option.
- An ASH poster presentation of the complete pivotal, Phase 2/3
trial results of Rylaze® (asparaginase erwinia
chrysanthemi (recombinant)-rywn) in acute lymphoblastic leukemia
(ALL) or lymphoblastic lymphoma (LBL), which includes efficacy,
safety and population pharmacokinetic modeling from intramuscular
(IM) and intravenous (IV) dosing. The combination of observed and
modeled results demonstrates Rylaze achieved therapeutic
nadir serum asparaginase activity (NSAA) levels in the vast
majority of patients via multiple dosing schedules with a safety
profile consistent with prior studies and no new safety signals
identified. Treatment‐related adverse events (TRAEs) ≥ grade 3
occurred in 126/228 (55%) patients with no TRAEs that led to
death.1
- Two NACLC poster presentations of real-world data for
Zepzelca® (lurbinectedin) in the second-line and later
settings for the treatment of small cell lung cancer (SCLC).
The Jazz and partner-supported presentations at SABCS 2023
are:
Zanidatamab Presentations
Presentation
Title
|
Author
|
Presentation
Details (All times CDT)
|
Primary Results From a
Phase 2a Study of Zanidatamab (zani) + Palbociclib (palbo) +
Fulvestrant (fulv) in HER2+/HR+ Metastatic Breast Cancer
(mBC)
|
Santiago
Escrivá-de-Romani, et al.
|
Type:
Oral
Session: Late
Breaking Abstracts
Presentation
Number: LBO1-04
Date/Time:
Friday, December 8, 2023, 12:20 PM – 12:25 PM
|
Neoadjuvant Zanidatamab
for Stage 1 Node Negative HER2 Positive Breast Cancer
(BC)
[IST]
|
V. Valero, et
al.
|
Type:
Poster
Session:
Spotlight poster session
Presentation
Number: PS09-03
Date / Time:
Wednesday, December 6, 2023, 5:30 PM – 6:30 PM
|
The Jazz-supported presentations at the 2023 ASH Annual Meeting
are:
Rylaze Presentations
Presentation
Title
|
Author
|
Presentation
Details (All times PDT)
|
Efficacy and Safety of
Recombinant Erwinia Asparaginase in Acute Lymphoblastic
Leukemia (ALL) or Lymphoblastic Lymphoma (LBL): Complete Follow-up
of the Children's Oncology Group (COG) AALL1931
study
|
Luke Maese, et al.
|
Type:
Poster
Number:
1498
Session: 614.
Acute Lymphoblastic Leukemias: Therapies, Excluding Transplantation
and Cellular Immunotherapies: Poster I
Date/Time:
Saturday, December 9, 5:30-7:30 PM
Abstract
Link
|
A Meta-analysis
Comparing the Relative Efficacy of Pediatric-Inspired Regimens
Versus Hyper-CVAD for the Treatment of Acute Lymphoblastic
Leukemia/Lymphoblastic Lymphoma in Adolescents, Young Adults and
Adults
|
Wenqing Su, et al.
|
Type:
Poster
Number:
3779
Session: 905.
Outcomes Research—Lymphoid Malignancies: Poster
II
Date/Time:
Sunday, December 10, 6:00-8:00 PM
Abstract
Link
|
Asparaginase Collaboration Studies
Presentation
Title
|
Author
|
Presentation
Details
|
Overcoming Venetoclax
(Ven) Resistance Through Glutamine (Gln) Depletion: Final Analysis
of the Phase 1 Trial of Ven and Pegcrisantaspase (PegC) Combination
in Relapsed and Refractory (R/R) Acute Myeloid Leukemia
(AML)
|
Yuchen Liu, et al.
|
Type:
Oral
Number:
60
Session: 616.
Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Upcoming Therapies in
Newly Diagnosed and Relapsed/Refractory AML
Date/Time:
Saturday, December 9, 10:45 AM
Abstract
link
|
Vyxeos Presentations
Presentation
Title
|
Author
|
Presentation
Details
|
Population
Pharmacokinetic-Pharmacodynamic Modeling of Neutrophil and Platelet
Count for Lower-Intensity Therapy of CPX-351 Combined With
Venetoclax in Acute Myeloid Leukemia
|
Yali Liang, et al.
|
Type:
Poster
Number:
2902
Session: 615.
Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster
II
Date/Time:
Sunday, December 10, 6:00-8:00 PM
Abstract
Link
|
CPX-351 With Venetoclax
in Patients with Relapsed/Refractory Acute Myeloid Leukemia:
Results of a Phase Ib Study
|
Alex Bataller, et al.
|
Type:
Poster
Number:
4259
Session: 615.
Acute Myeloid Leukemias: Commercially Available Therapies,
Excluding Transplantation and Cellular Immunotherapies: Poster
III
Date/Time:
Monday, December 11, 6:00-8:00 PM
Abstract
link
|
Phase 2 Study of
CPX-351 in Combination with Venetoclax in Patients with Newly
Diagnosed, High Risk Acute Myeloid Leukemia
|
Wei-Ying Jen, et al.
|
Type:
Poster
Number:
4273
Session:
615. Acute Myeloid Leukemias: Commercially Available
Therapies, Excluding Transplantation and Cellular Immunotherapies:
Poster III
Date/Time:
Monday, December 11, 6:00-8:00 PM
Abstract
link
|
Results of a Phase 1/2
Study of Lower Dose CPX-351 for Patients with Int-2 or High Risk
IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
after Failure to Hypomethylating Agents
|
Guillermo
Montalban-Bravo, et al.
|
Type:
Poster
Number:
1873
Session: 637.
Myelodysplastic Syndromes Clinical and Epidemiological: Poster
I
Date/Time:
Saturday, Dec. 9, 5:30 PM-7:30 PM
Abstract link
|
CRISPR/Cas9 Screen
Identifies CPX-351 and 7+3 Regimens Response Modulators with
Distinct Sensitive and Resistant Profiles
[IST]
|
Nam Nguyen, et al.
|
Type:
Poster
Number:
1412
Session: 604.
Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms:
Poster I
Date/Time:
Saturday, Dec. 9, 5:30-7:30 PM
Abstract
link
|
CPX-351 in Patients
with Newly Diagnosed Post Myeloproliferative Neoplasms Acute
Myeloid Leukemia
[IST]
|
Sylvain Garciaz, et
al.
|
Type:
Poster
Number:
2917
Session: 616.
Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster II
Date/Time:
Sunday, Dec. 10, 6:00-8:00 PM
Abstract
link
|
Defitelio Presentations
Presentation
Title
|
Author
|
Presentation
Details
|
Resolution of
Veno-occlusive Disease/Sinusoidal Obstruction Syndrome (VOD/SOS)
With Defibrotide Following HCT in Adult and Pediatric Patients:
Pooled Analysis of DEFIFrance and EBMT PASS
Registries
|
Mohamad Mohty, et
al.
|
Type:
Poster
Number:
3527
Session: 721.
Allogeneic Transplantation: Conditioning Regimens, Engraftment and
Acute Toxicities: Poster II
Date/Time:
Sunday, December 10, 6:00-8:00 PM
Abstract
link
|
A Phase II Study to
Evaluate the Safety and Efficacy of Defibrotide and Changes in
Plasma Biomarkers in Sickle Cell Disease-Related Acute Chest
Syndrome (IND 127812)
[IST]
|
Edo Schaefer, et al.
|
Type:
Poster
Number:
2520
Session: 114.
Sickle cell Disease, Sickle Cell Trait and Other
Hemoglobinopathies, Excluding Thalassemias: Clinical and
Epidemiological: Poster II
Date/Time:
Sunday, December 10, 6:00-8:00 PM
Abstract
link
|
The Jazz-supported presentations at NACLC 2023
are:
Zepzelca Presentations
Presentation
Title
|
Author
|
Presentation
Details (All times CDT)
|
Real-World Use of
Lurbinectedin in Patients with Small Cell Lung Cancer: Jazz EMERGE
402 Updated Analysis
|
Balazs Halmos, et
al.
|
Type:
Poster
Number:
PP01.119
Session: Poster
Viewing Reception
Date/Time:
Saturday, December 2, 5:40-6:55 PM CT
|
Real-World
Effectiveness and Safety Profile of Lurbinectedin and Other
Second-Line Treatments in Small Cell Lung Cancer
|
Apar Ganti, et
al.
|
Type:
Poster
Number:
PP01.117
Session: Poster
Viewing Reception
Date/Time:
Saturday, December 2, 2023/5:40-6:55 PM CT
|
About Zanidatamab
Zanidatamab is an investigational bispecific antibody that can
simultaneously bind two non-overlapping epitopes of HER2, known as
biparatopic binding. This unique design results in multiple
mechanisms of action including dual HER2 signal blockade, increased
binding and removal of HER2 protein from the cell surface, and
immune-mediated cytotoxicity leading to encouraging antitumor
activity in patients. Zanidatamab is being developed in multiple
clinical trials as a targeted treatment option for patients with
solid tumors that express HER2. Zanidatamab is being developed
by Jazz and BeiGene, Ltd. (BeiGene) under license
agreements from Zymeworks, which first developed the
molecule.
The U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy designation for zanidatamab in
patients with previously treated HER2 gene-amplified biliary tract
cancers (BTC), and two Fast Track designations for zanidatamab: one
as a single agent for refractory BTC and one in combination with
standard of care chemotherapy for first-line gastroesophageal
adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan
Drug designations from FDA for the treatment of BTC and GEA, as
well as Orphan Drug designation from the European Medicines
Agency for the treatment of BTC and gastric cancer.
Zanidatamab was also granted Breakthrough Therapy designation from
the Center for Drug Evaluation (CDE)
in China.
About RYLAZE® (asparaginase
erwinia chrysanthemi (recombinant)-rywn)
RYLAZE, also known as JZP458, is approved in the U.S. for
use as a component of a multi-agent chemotherapeutic regimen for
the treatment of acute lymphoblastic leukemia (ALL) and
lymphoblastic lymphoma (LBL) in adult and pediatric patients one
month or older who have developed hypersensitivity to E.
coli-derived asparaginase. RYLAZE has orphan drug
designation for the treatment of ALL/LBL in the United States.
RYLAZE, or recombinant Erwinia is a short-acting
distinct asparaginase derived from a novel Pseudomonas
fluorescens expression platform to help ensure
robustness of supply to meet patient needs. JZP458 was granted Fast
Track designation by the U.S. Food and Drug
Administration (FDA) in October 2019 for the
treatment of this patient population. RYLAZE was approved as part
of the Real-Time Oncology Review program, an initiative of the
FDA's Oncology Center of Excellence designed for efficient delivery
of safe and effective cancer treatments to
patients.2
The full U.S. Prescribing Information for RYLAZE is
available at:
https://pp.jazzpharma.com/pi/rylaze.en.USPI.pdf
Important Safety Information for Rylaze
RYLAZE
should not be given to people who have had:
- Serious allergic reactions to RYLAZE
- Serious swelling of the pancreas (stomach pain), serious blood
clots, or serious bleeding during previous asparaginase
treatment
RYLAZE may cause serious side effects,
including:
- Allergic reactions (a feeling of tightness in your throat,
unusual swelling/redness in your throat and/or tongue, or trouble
breathing), some of which may be life-threatening
- Swelling of the pancreas (stomach pain), which, if left
untreated, may be fatal
- Blood clots (may be experienced as headache, arm or leg
swelling, shortness of breath, or chest pain), which may be
life-threatening
- Bleeding, which may be life-threatening
- Liver problems
Contact your doctor immediately if any of these side effects
occur.
Some of the most common side effects with
RYLAZE include: liver problems, nausea and vomiting,
bone and muscle pain, infection, tiredness, headache, fever with
low white blood cell count, fever, bleeding, mouth swelling
(sometimes with sores), pain in the abdomen, decreased appetite,
allergic reactions, high blood sugar levels, diarrhea, swelling of
the pancreas, and low levels of potassium in your blood.
RYLAZE can harm your unborn baby. Inform your doctor if you are
pregnant, planning to become pregnant, or nursing. Females of
reproductive potential should use effective contraception (other
than hormonal contraceptives) during treatment and for 3 months
following the final dose. Do not breastfeed while receiving
RYLAZE and for 1 week after the final dose.
Tell your healthcare provider if there are any side effects
that are bothersome or that do not go away.
These are not all the possible side effects of RYLAZE. For
more information, ask your healthcare provider.
Call your doctor for medical advice about any 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
(1-800-332-1088).
About Vyxeos® (daunorubicin
and cytarabine) liposome for injection
Vyxeos is a liposomal combination of daunorubicin, an
anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside
metabolic inhibitor.
In the U.S., Vyxeos (daunorubicin and
cytarabine) liposome for injection 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.3
More information about Vyxeos in the United States, including Full Prescribing
Information and BOXED Warning, is
available here.
Important Safety Information for
VYXEOS®
WARNING: 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:
shortness of breath or trouble breathing
swelling or fluid retention, especially in the feet, ankles, or
legs
unusual tiredness
VYXEOS may cause allergic reactions including
anaphylaxis. Seek immediate medical attention if you develop
signs and symptoms of anaphylaxis such as:
trouble breathing
severe itching
skin rash or hives
swelling of the face, lips, mouth, or tongue
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 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.
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 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.6
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 Defitelio
Defitelio
should not be given to patients who are:
- Currently taking anticoagulants or fibrinolytics
- Allergic to Defitelio or any of its ingredients
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 Zepzelca® (lurbinectedin)
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.4
The FDA approved Zepzelca under
accelerated approval in June 2020 for the treatment of
adult patients with metastatic SCLC with disease progression on or
after platinum-based chemotherapy. The approval is based on overall
response rate (ORR) and duration of response demonstrated in an
open-label, monotherapy clinical study. In December 2021,
Jazz and PharmaMar announced the initiation of LAGOON, a
confirmatory Phase 3 clinical trial
of Zepzelca for the treatment of patients with
relapsed small cell lung cancer. If positive, LAGOON could confirm
the benefit of Zepzelca in the treatment of small cell lung
cancer (SCLC) when patients progress following 1L treatment with a
platinum-based regimen and support full approval in
the U.S.
Zepzelca is a prescription medicine used to treat
adults with SCLC 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:
- have liver or kidney problems.
- are pregnant or plan to become pregnant. ZEPZELCA can harm your
unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you
start treatment with ZEPZELCA.
- You should use effective birth control (contraception) during
treatment with and for 6 months after your final dose of
ZEPZELCA.
- Tell your healthcare provider right away if you become pregnant
or think that you are pregnant during treatment with ZEPZELCA.
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.
Females who are breastfeeding or plan to breastfeed. It is not
known if ZEPZELCA passes into your breastmilk. Do not breastfeed
during treatment with ZEPZELCA and for 2 weeks after your final
dose of ZEPZELCA. Talk to your healthcare provider about the best
way to feed your baby during treatment with 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:
- Low blood cell counts. Low blood counts including low
neutrophil counts (neutropenia) and low platelet counts
(thrombocytopenia) are common with ZEPZELCA, and can also be
severe. Some people with low white blood cell counts may get fever,
or an infection throughout the body (sepsis), that can cause death.
Your healthcare provider should do blood tests before you receive
each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you
develop:
- fever or any other signs of infection
- unusual bruising or bleeding
- tiredness
- pale colored skin
- Liver problems. Increased liver function tests are
common with ZEPZELCA, and can also be severe. Your healthcare
provider should do blood tests to check your liver function before
you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop
symptoms of liver problems including:
- loss of appetite
- nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- 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:
- Tiredness
- low white and red blood cell counts
- increased kidney function blood test (creatinine)
- increased liver function blood tests
- increased blood sugar (glucose)
- nausea
- decreased appetite
- muscle and joint (musculoskeletal) pain
- low level of albumin in the blood
- constipation
- trouble breathing
- low levels of sodium and magnesium in the blood
- vomiting
- cough
- diarrhea
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 Pharma Mar, S.A. used
by Jazz Pharmaceuticals under license.
About Jazz Pharmaceuticals
Jazz 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. Within these therapeutic areas, we are identifying
new options for patients by actively exploring small molecules and
biologics, and through innovative delivery technologies and
cannabinoid science. Jazz is headquartered in Dublin,
Ireland and has employees around the globe, serving patients
in nearly 75 countries. Please
visit www.jazzpharmaceuticals.com for more
information.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including,
but not limited to, statements related to improving
standards of care in blood cancer and other hematologic
diseases 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's Securities 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, 2022, as
supplemented by our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023, 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:
Jazz Media Contact:
Kristin
Bhavnani
Head of Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Jazz Investor Contact:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634
3211
U.S. +1 650 496 2717
References
1 Maese L, et al. Efficacy and Safety of
Intramuscular (IM) Recombinant Erwinia Asparaginase in Acute
Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL): The
Children's Oncology Group (COG) AALL1931 study. American Society of
Hematology. 2023. Available at
https://ash.confex.com/ash/2023/webprogram/Paper172577.html
2 Rylaze (asparaginase erwinia chrysanthemi
(recombinant)-rywn) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.
3 Vyxeos (daunorubicin and cytarabine) Prescribing
Information. Palo Alto, CA: Jazz Pharmaceuticals,
Inc.
4 ZEPZELCA (lurbinectedin) Prescribing Information.
Palo Alto, CA: Jazz
Pharmaceuticals, Inc.
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SOURCE Jazz Pharmaceuticals plc