17:33:31 AMGN - FDA to Review Potential New Use of XGEVA(R) (Denosumab) at Oncologic Drugs Advisory Committee Meeting
(Denosumab) at Oncologic Drugs Advisory Committee Meeting
PR Newswire
THOUSAND OAKS, Calif., Dec. 29, 2011
THOUSAND OAKS, Calif., Dec. 29, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN)
today announced the U.S. Food and Drug Administration (FDA) has invited the
Company to participate in a meeting of the Oncologic Drugs Advisory Committee
(ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License
Application (sBLA) for XGEVA(R) (denosumab) to treat men with
castration-resistant prostate cancer (CRPC) at high risk of developing bone
metastases.
The ODAC will review results from clinical studies in support of this new
indication, including the pivotal '147 trial, a randomized, placebo-controlled,
multi-center Phase 3 study that compared XGEVA to placebo in prolonging bone
metastasis-free survival in men with non-metastatic CRPC who were at high risk
for bone metastases based on prostate specific antigen criteria.
Amgen plans to discuss the proposed sBLA with ODAC, to support the use of
XGEVA in the treatment of men with non-metastatic CRPC; a patient population
for whom there are no approved treatments to delay or prevent the spread of
cancer to bone.
The sBLA was submitted on June 27, 2011, and a Prescription Drug User Fee Act
action date has been scheduled for April 26, 2012. If approved, this will be
the second indication for XGEVA in the United States (U.S.).
About XGEVA
XGEVA is the first and only RANK Ligand inhibitor approved by the FDA
indicated for the prevention of skeletal-related events (SREs) in patients with
bone metastases from solid tumors. XGEVA was initially approved following a six
month priority review by the FDA. XGEVA is not indicated for the prevention of
SREs in patients with multiple myeloma. XGEVA is the first novel bone
metastases treatment for advanced cancer patients in nearly a decade. Delivered
as an every four week 120 mg subcutaneous injection, XGEVA provides a unique
option for urologists and oncologists to prevent SREs in patients with bone
metastases from solid tumors.
XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a
protein essential for the formation, function and survival of osteoclasts (the
cells that break down bone). XGEVA prevents RANK Ligand from activating its
receptor, RANK, on the surface of osteoclasts, thereby decreasing bone
destruction.
XGEVA has been studied in over 7,000 patients with cancer. In clinical
trials, XGEVA demonstrated a clinically meaningful improvement compared to the
previous standard of care in preventing bone complications. XGEVA is also being
investigated for the potential use to delay the onset of bone metastasis in
adjuvant breast cancer.
XGEVA Important Safety Information
XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior
to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium
and vitamin D as necessary. Advise patients to contact a healthcare
professional for symptoms of hypocalcemia.
Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA.
Patients who are suspected of having or who develop ONJ while on XGEVA should
receive care by a dentist or an oral surgeon. In these patients, extensive
dental surgery to treat ONJ may exacerbate the condition.
The most common adverse reactions in patients receiving XGEVA were
fatigue/asthenia, hypophosphatemia and nausea. The most common serious adverse
reaction in patients receiving XGEVA was dyspnea. The most common adverse
reactions resulting in discontinuation of XGEVA were osteonecrosis and
hypocalcemia. Please visit www.amgen.com or www.xgeva.com for full U.S.
prescribing information.
XGEVA Regulatory Status
XGEVA has been approved in the U.S., Canada, the European Union (EU),
Switzerland, Australia and Russia for the prevention of SREs in patients with
bone metastases from solid tumors. XGEVA is not approved to prevent SREs in
patients with multiple myeloma.
Amgen has also submitted marketing applications for XGEVA in Mexico, South
Africa, Gulf Cooperation Council countries, Morocco, and Egypt. In Japan, Amgen
is working with its licensing partner, Daiichi Sankyo Company, Limited and a
marketing application was submitted. In addition, Amgen and GlaxoSmithKline
(GSK) have a collaboration agreement for the commercialization of XGEVA in a
number of countries where Amgen does not currently have a commercial presence.
In these countries, marketing applications are filed by GSK.
Bone Metastases and SREs: Prevalence and Impact
Bone metastases occur in more than 1.5 million patients with cancer worldwide
and are most commonly associated with cancers of the prostate, lung, and
breast, with incidence rates as high as 90 percent of patients with metastatic
disease. [ii] [iii] [iv]
Approximately 50-70 percent of cancer patients with bone metastases will
experience debilitating SREs.[v] [vi] [vii] Events considered to be SREs
include fractures, spinal cord compression, and severe bone pain that may
require surgery or radiation. [viii] Such events can profoundly disrupt a
patient's life and can cause disability and pain. [ix] [x] [xi]
Denosumab and Amgen's Research in Bone Biology
The denosumab development program demonstrates Amgen's commitment to
researching and delivering pioneering medicines to patients with unmet medical
needs. Amgen is studying denosumab in numerous tumor types across the spectrum
of cancer-related bone diseases. Over 11,000 patients have been enrolled in the
denosumab oncology clinical trials. In addition to the prevention of SREs,
XGEVA is also being evaluated for its potential to delay bone metastases in
adjuvant breast cancer.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have
changed the practice of medicine, helping millions of people around the world
in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease
and other serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our vital
medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.
Forward Looking Statements
This news release contains forward-looking statements that are based on
management's current expectations and beliefs 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 fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or 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, including
Amgen's most recent annual report on Form 10-K and most recent periodic reports
on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing this
information as of Dec. 29, 2011 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 we project. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate or development
of a new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe and
effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
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and future products and limits on supply may constrain sales of certain of our
current products and product candidate development.
(MORE TO FOLLOW) Dow Jones Newswires
12-29-11 1733ET
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