THOUSAND OAKS, Calif.,
March 30, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced that the U.S. Food and Drug
Administration (FDA) has accepted the supplemental New Drug
Application (sNDA) of Kyprolis® (carfilzomib) for
Injection for the treatment of patients with relapsed multiple
myeloma who have received at least one prior therapy. The sNDA is
designed to support the conversion of accelerated approval to full
approval and expand the current Kyprolis indication. As part of the
acceptance, the FDA granted Kyprolis priority review with a
Prescription Drug User Fee Act (PDUFA) target action date of
July 26, 2015.
"Achieving deep and durable responses for patients with relapsed
multiple myeloma is critical towards extending the time they live
without their disease progressing," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "The FDA's priority review
designation for Kyprolis underscores the need for new treatment
options for patients with relapsed multiple myeloma, and we look
forward to working with regulatory authorities throughout the
review process."
The sNDA is based on data from the Phase 3 ASPIRE
(CArfilzomib, Lenalidomide, and DexamethaSone versus
Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial and other relevant data.
Priority review is assigned to applications for drugs that treat
serious conditions and would, if approved, provide significant
improvements in the safety or effectiveness of the treatment,
diagnosis, or prevention of serious conditions.1
Kyprolis is currently approved by the FDA for the treatment of
patients with multiple myeloma who have received at least two prior
therapies, including bortezomib and an immunomodulatory agent
(IMiD), and have demonstrated disease progression on or within 60
days of completion of the last therapy.
About ASPIRE
The international, randomized Phase 3
ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone
versus Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial evaluated Kyprolis in combination with
lenalidomide and low-dose dexamethasone, versus lenalidomide and
low-dose dexamethasone alone, in patients with relapsed multiple
myeloma following treatment with one to three prior regimens. The
primary endpoint of the trial was progression-free survival,
defined as the time from treatment initiation to disease
progression or death. Secondary endpoints included overall
survival, overall response rate, duration of response, disease
control rate, health-related quality of life and safety. Patients
were randomized to receive Kyprolis (20 mg/m2 on days 1
and 2 of cycle 1 only, escalating to 27 mg/m2 on days 8,
9, 15 and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15 and
16 of subsequent cycles), in addition to a standard dosing schedule
of lenalidomide (25 mg per day for 21 days on, 7 days off) and
low-dose dexamethasone (40 mg per week in 4 week cycles), versus
lenalidomide and low-dose dexamethasone alone. The study randomized
792 patients at sites in North
America, Europe and
Israel.
The ASPIRE data were presented at the 56th Annual
Meeting of the American Society of Hematology in December 2014 and published in the New England
Journal of Medicine.
The European Medicines Agency (EMA) provided Scientific Advice
on the design and planned analysis of the ASPIRE trial and it was
conducted under a Special Protocol Assessment (SPA) from the
FDA.
About Multiple Myeloma
Multiple myeloma is the second
most common hematologic cancer and results from an abnormality of
plasma cells, usually in the bone marrow.1,2 Worldwide,
nearly 230,000 people are living with multiple myeloma and
approximately 114,000 new cases are diagnosed
annually.3 In the U.S., there are nearly 96,000
people living with, or in remission from, multiple myeloma. The
estimated number of new cases of multiple myeloma in 2014 was more
than 24,000 and the estimated number of deaths was
11,090.4 In Europe,
approximately 89,000 people are living with the disease and in 2012
there was an estimated 39,000 newly diagnosed cases and 24,000
deaths.3
About Kyprolis® (carfilzomib) for
Injection
On July 20, 2012,
the U.S. FDA granted accelerated approval of Kyprolis®
(carfilzomib) for Injection for the treatment of patients with
multiple myeloma who have received at least two prior therapies
including bortezomib and an immunomodulatory agent (IMiD) and have
demonstrated disease progression on or within 60 days of completion
of the last therapy. Approval was based on response rate. Clinical
benefit, such as improvement in survival or symptoms, has not been
verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx
Pharmaceuticals is a subsidiary of Amgen and holds development and
commercialization rights to Kyprolis globally, excluding
Japan. Kyprolis is also approved
for use in Argentina, Israel and Mexico. For more information about Kyprolis,
visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis®
(carfilzomib) for Injection
This safety information is
specific to the current U.S. approved indication, which is based on
Phase 2 studies.
Safety data have been evaluated in 526 patients with relapsed
and/or refractory multiple myeloma who received single-agent
Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent
of patients. The most common causes of death, other than disease
progression, were cardiac events (5 patients), end-organ failure (4
patients) and infection (4 patients). Important warnings and
precautions include cardiac arrest, congestive heart failure,
myocardial ischemia, pulmonary hypertension, pulmonary
complications, infusion reactions, tumor lysis syndrome,
thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of
Kyprolis administration. Patients with New York Heart Association
Class III and IV heart failure, myocardial infarction in the
preceding 6 months and conduction abnormalities uncontrolled by
medications were not eligible for the clinical trials. These
patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2 percent
of patients treated with Kyprolis and was Grade 3 or greater in
less than 1 percent of patients. Dyspnea was reported in 35 percent
of patients enrolled in clinical trials. Grade 3 dyspnea occurred
in 5 percent; no Grade 4 events and 1 death (Grade 5) was
reported.
Infusion reactions, characterized by a spectrum of systemic
symptoms including fever, chills, arthralgia, myalgia, facial
flushing, facial edema, vomiting, weakness, shortness of breath,
hypotension, syncope, chest tightness, or angina can occur
immediately following or up to 24 hours after administration of
Kyprolis. Administration of dexamethasone prior to Kyprolis reduces
the incidence and severity of reactions. Tumor lysis syndrome (TLS)
occurred following Kyprolis administration in <1 percent of
patients. Patients with multiple myeloma and a high tumor burden
should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a
dose reduction in 1 percent of patients and discontinuation of
treatment with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been
reported (<1 percent). Kyprolis can cause elevations of serum
transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant
women using Kyprolis. Females of reproductive potential should be
advised to avoid becoming pregnant while being treated with
Kyprolis.
The most common serious adverse reactions were pneumonia, acute
renal failure, pyrexia and congestive heart failure. The most
common adverse reactions (incidence of 30 percent or greater)
observed in clinical trials of patients with multiple myeloma were
fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and
pyrexia. Serious adverse reactions were reported in 45 percent of
patients.
Full prescribing information is available at
www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen)
and are subject to a number of risks, uncertainties and assumptions
that could cause actual results to differ materially from those
described. All statements, other than statements of historical
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practices, customer and prescriber patterns or practices,
reimbursement activities and outcomes and other such estimates and
results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully
described in the Securities and Exchange Commission (SEC) reports
filed by Amgen Inc., including Amgen Inc.'s most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms
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and risk factors related to Amgen's business. Unless otherwise
noted, Amgen is providing this information as of March 30, 2015, and expressly disclaims any duty
to update information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects. Discovery
or identification of new product candidates or development of new
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In addition, sales of Amgen's products (including products of
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The scientific information discussed in this news release
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CONTACT:
Danielle Bertrand, 650-266-2114
(Media)
Cuyler Mayer, 805-447-6332
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
- Dimopoulos, M.A. Multiple Myeloma. Annals of Oncology 21
(Supplement 7): vii143–vii150, 2010.
- National Cancer Institute. SEER Stat Fact Sheets: Myeloma.
Available at: http://seer.cancer.gov/statfacts/html/mulmy.html.
Accessed June 2014.
- International Agency for Research on Cancer, GLOBOCAN 2012
database. Available at http://globocan.iarc.fr/. Accessed
February 2014.
- Leukemia & Lymphoma Society. Facts 2014-2015.
http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/generalcancer/pdf/facts.pdf
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