THOUSAND OAKS, Calif. and
SOUTH SAN FRANCISCO, Calif.,
Feb. 26, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) and its subsidiary Onyx Pharmaceuticals, Inc., today
announced that the European Medicines Agency (EMA) has accepted the
Marketing Authorization Application (MAA) of Kyprolis®
(carfilzomib) for Injection for the treatment of patients with
relapsed multiple myeloma who have received at least one prior
therapy. The MAA has been granted accelerated assessment by the
EMA.
Kyprolis is a proteasome inhibitor, one of the classes of drugs
used to treat multiple myeloma, an incurable blood cancer affecting
approximately 89,000 people in Europe.1 Nearly all patients with
the disease experience periods of remission, followed by relapses
and eventually their disease becomes resistant to treatment.
"Achieving deep and durable responses for patients with relapsed
multiple myeloma is critical towards extending the time they live
without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx
Pharmaceuticals, Inc. "We look forward to working with European
regulators to potentially make this important medication
available."
The MAA includes data from the Phase 3 ASPIRE
(CArfilzomib, Lenalidomide, and DexamethaSone versus
Lenalidomide and Dexamethasone for the treatment of
PatIents with Relapsed Multiple
MyEloma) trial as well as other relevant data.
Kyprolis previously received orphan drug designation by the EMA
in the European Union (EU). Orphan designation is granted for
medicines intended for the treatment, prevention or diagnosis of a
disease that is life threatening and has a prevalence in the EU of
no more than five in 10,000. The intended medicine must aim to
provide significant benefit to those affected by the
condition.2
Kyprolis was granted accelerated approval by the U.S. Food and
Drug Administration (FDA) in July
2012. Kyprolis is also approved for use in Argentina, Israel and Mexico.3-5
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.6 Worldwide,
nearly 230,000 people are living with multiple myeloma.1
In 2012, approximately 114,000 new cases were diagnosed and 80,000
people died.7 In Europe, approximately 89,000 people are living
with multiple myeloma. Approximately 39,000 new cases were
diagnosed and 24,000 people died in 2012.1 In the U.S.,
approximately 83,000 people were living with multiple myeloma in
2011. The estimated number of new cases in 2014 was 24,000 and the
estimated number of deaths was 11,000.8
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.
Onyx Pharmaceuticals received Scientific Advice from the EMA on
the design and planned analysis of the ASPIRE trial and it was
conducted under a Special Protocol Assessment (SPA) from the
FDA.
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. For more information about
Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis®
(carfilzomib) for Injection U.S. Indication
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.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx
Pharmaceuticals, Inc., an Amgen subsidiary, is a global
biopharmaceutical company engaged in the development and
commercialization of innovative therapies for improving the lives
of people with cancer. The company is focused on developing novel
medicines that target key molecular pathways. For more information
about Onyx, visit the company's website at www.onyx.com. Onyx
Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed
@OnyxPharm at http://twitter.com/OnyxPharm.
Forward-Looking Statements
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forward-looking statements that are based on the current
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and are subject to a number of risks, uncertainties and assumptions
that could cause actual results to differ materially from those
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noted, Amgen is providing this information as of Feb. 26, 2015 and expressly disclaims any duty to
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CONTACT: Amgen
Lindsay Treadway, 650-266-5346 (Onyx
media)
Cuyler Mayer, 805-447-6332 (Amgen
media)
Arvind Sood, 805-447-1060
(investors)
References:
1 Bray F, Ren JS, Masuyer E,
Ferlay J. Estimates of global cancer prevalence for 27 sites in the
adult population in 2008. Int J Cancer. 2013 Mar. 1;132(5):1133-45. doi: 10.1002/ijc.27711.
Epub 2012 Jul 26.
2 European Medicines Agency. Orphan designation
criteria. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp.
Accessed January 2015.
3 Varifarna Press Release.
http://www.varifarma.com.ar/noticias/5/90/Lanzamiento-Kyprolis-Carfilzomib-en-Argentina/.
Accessed January 2015.
4 Israel Drug Registry.
http://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=151%2021%2033948%20
00&NewTruf=2&safa=. Accessed January
2015
5 Amgen Press Release. Available at:
http://www.lasalud.mx/permalink/13981.html. Accessed January 2015.
6 Dimopoulous, MA, San-Miguel, JF, Anderson, KC. Emerging therapies for the
treatment of relapsed or refractory multiple myeloma. European
Journal of Haematology. 2011; Jan 86(1):1-15.
7 Ferlay J, et al. GLOBOCAN 2012 v1.0, Cancer Incidence
and Mortality Worldwide: IARC CancerBase No. 11 [Internet].
Lyon, France: International Agency
for Research on Cancer; 2013. Available from:
http://globocan.iarc.fr, accessed on 15/January/2015.
8 National Cancer Institute. SEER Stat Fact Sheets:
Myeloma. http://seer.cancer.gov/statfacts/html/mulmy.html.
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