DUBLIN, Feb. 8, 2018 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the
National Comprehensive Cancer Network®
(NCCN®) added Vyxeos™ (daunorubicin and cytarabine)
liposome for injection to the Clinical Practice Guidelines in
Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia
(AML).
The United States Food and Drug Administration (FDA) approved
Vyxeos on August 3, 2017 for
the treatment of adults with two types of AML, a rapidly
progressing and life-threatening blood cancer. Vyxeos is the
first FDA-approved treatment specifically for adults with
newly-diagnosed Therapy-Related AML (t-AML) or AML with
Myelodysplasia-Related Changes (AML-MRC). Based on the data from
the pivotal Phase 3 randomized trial of Vyxeos versus the
standard of care, the NCCN Guidelines now include a Category 1
recommendation for use of Vyxeos for adult patients 60 years
of age or greater with newly-diagnosed t-AML or AML-MRC. The
Category 1 recommendation indicates that based upon high-level
evidence, there is uniform NCCN consensus that Vyxeos is
appropriate for these patients.
"We appreciate the decision by the NCCN to incorporate
Vyxeos into the Clinical Practice Guidelines in Oncology as
it supports our commitment to ensuring that patients, through their
health care professionals, are able to access this important new
treatment option," said Karen Smith,
M.D., Ph.D., executive vice president of research and development
and chief medical officer of Jazz Pharmaceuticals. "Vyxeos
is the first chemotherapy advance for adults with newly-diagnosed
t-AML or AML-MRC in more than 40 years."
The NCCN, a not-for-profit alliance of 27 leading U.S. cancer
centers devoted to patient care, research, and education, is
dedicated to improving the quality, effectiveness, and efficiency
of cancer care. The intent of the NCCN Guidelines is to assist in
the decision-making process of individuals involved in cancer
care—including physicians, nurses, pharmacists, payers, patients
and their families—with the ultimate goal of improving patient care
and outcomes.
About Vyxeos™
Vyxeos™ (daunorubicin and cytarabine) liposome for injection
44mg/100mg is a liposome formulation of a fixed combination of
daunorubicin and cytarabine for intravenous
infusion.1 Vyxeos is indicated for the
treatment of adults with newly-diagnosed t-AML or AML-MRC. For
more information about Vyxeos in the United States, please visit
https://vyxeos.com.
Important Safety Information
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 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.
Please see full Prescribing Information for Vyxeos before
prescribing: http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf
About AML
Acute myeloid leukemia (AML) is a blood cancer that begins in
the bone marrow, which produces most of the body's new blood
cells.2 AML cells crowd out healthy cells and move
aggressively into the bloodstream to spread cancer to other parts
of the body.3 AML is a relatively rare disease
representing 1.3 percent of all new cancer cases.4 It is
estimated that more than 21,000 people will be diagnosed with AML
in the United States this year
with the potential for nearly 11,000 people to die from the
disease.5 The median age at diagnosis is 68 years
old,4 with rising age associated with a progressively
worsening prognosis.6 There is also a reduced tolerance
for intensive chemotherapy as patients age.7 AML has the
lowest survival rate of any other form of leukemia.4
Patients with newly diagnosed t-AML or AML-MRC may have a
particularly poor prognosis.8-10 A hematopoietic
stem cell transplant (HSCT) may be a curative treatment option for
patients.11
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 Erwinaze® and Defitelio®
(defibrotide) in countries outside the U.S. For country-specific
product information, please
visit www.jazzpharmaceuticals.com/products. For more
information, please visit www.jazzpharmaceuticals.com and
follow us on Twitter at @JazzPharma.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
This press release contains forward-looking statements,
including, but not limited to, statements related to the addition
of Vyxeos to the NCCN Guidelines, Jazz Pharmaceuticals' commitment
to ensuring that patients are able to access Vyxeos, and other
statements that are not historical facts. These
forward-looking statements are based on the company's 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: whether the
addition of Vyxeos to the NCCN Guidelines will improve access to
Vyxeos by patients covered by the NCCN Guidelines; the company's
ability to effectively commercialize Vyxeos in the U.S.; and delays
or problems in the supply or manufacture of Vyxeos; and other risks
and uncertainties affecting the company, 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 the
company's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2017 and future filings
and reports by the company. Other risks and uncertainties of
which the company is not currently aware may also affect the
company's forward-looking statements and may cause actual results
and 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 the company on its website or otherwise. The
company 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.
References:
- Vyxeos [package insert]. Palo Alto,
CA: Jazz Pharmaceuticals; 2017.
- National Cancer Institute. General Information About Adult
Acute Myeloid Leukemia
https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq
Accessed June 7, 2017.
- American Cancer Society. What is Acute Myeloid Leukemia?
https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html
Accessed March 20, 2017.
- SEER Stat Facts: AML. 2017.
- American Cancer Society. Key Statistics About Acute Myeloid
Leukemia.
https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
Accessed March 20, 2017.
- Baer MR, et al., Leukemia, 2011 May;
25(5):10.1038/eu.2011.9.
- Klepin HD. Hematology Am Soc Hematol Educ Program.
2014;2014(1):8-13.
- Goldstone AH, Burnett AK, Avivi I et al. Secondary acute
myeloid leukemia has a worse outcome than de novo AML, even taking
into account cytogenetics and age. AML 10, 11, 12 MRC Trials. Blood
2002; 100 (88a): (Abstr 322).
- Schiller GJ, Hematol Educ Program, 2013:201-208.
- Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C.
Prognosis in therapy-related acute myeloid leukemia and impact of
karyotype. J Clin Oncol. 2004 Jun 15;22(12):2510-1.
- Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6):
857–859. doi: 10.3324/haematol.2010.023184.
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