THOUSAND OAKS, Calif.,
May 13, 2015 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced that data at the
51st Annual Meeting of the American Society of Clinical
Oncology (ASCO) will showcase the Company's continued efforts
across both pipeline and marketed products, including key results
in the treatment of solid tumors and hematologic malignancies.
"The data at ASCO reflect our significant progress in developing
treatments across our oncology pipeline and portfolio," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Our focus is
to address unmet needs for patients by translating innovation in
research into much-needed therapeutic options."
Key data include new findings from clinical trials in multiple
myeloma, breast cancer, metastatic melanoma, acute lymphoblastic
leukemia (ALL) and metastatic colorectal cancer (mCRC).
Latest Research in Hematologic Malignancies:
Kyprolis ® (carfilzomib) for Injection
In
multiple myeloma, full results are being presented from the Phase 3
head-to-head ENDEAVOR trial evaluating Kyprolis compared to
Velcade® (bortezomib), as well as results from the Phase
1/2 CHAMPION-1 study and a secondary analysis from the pivotal
Phase 3 ASPIRE study.
- Carfilzomib and dexamethasone vs. bortezomib and
dexamethasone in patients with relapsed multiple myeloma: results
from the Phase 3 study ENDEAVOR
Abstract No. 8509, Lymphoma
and Plasma Cell Disorders Oral Abstract Session, Tuesday, June 2, 9:45 a.m.
to 12:45 p.m. CT (Presentation Time: 9:57 a.m. to 10:09 a.m. CT), E354b
- Updated results from CHAMPION-1, a Phase 1/2 study
investigating weekly carfilzomib with dexamethasone for patients
with relapsed or refractory multiple myeloma
Abstract No.
8527, Lymphoma and Plasma Cell Disorders Poster Session,
Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A
- Effect of carfilzomib, lenalidomide, and dexamethasone vs.
lenalidomide and dexamethasone in patients with relapsed multiple
myeloma by line of therapy: secondary analysis from an interim
analysis of the Phase 3 study ASPIRE
Abstract No. 8525,
Lymphoma and Plasma Cell Disorders Poster Session, Sunday, May 31, 8 a.m. to
11:30 a.m. CT, S Hall A
BLINCYTO® (blinatumomab)
BLINCYTO
data at ASCO will focus on targeted patient populations within
adult relapsed/refractory ALL to better understand response to
treatment.
- Re-exposure to blinatumomab after CD19-positive relapse:
Experience from three trials in patients with relapsed/refractory
B-precursor acute lymphoblastic leukemia
Abstract No. 7051,
Leukemia, Myelodysplasia, and Transplantation Poster Session,
Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A
- Safety and activity of blinatumomab for older patients with
relapsed/refractory B-precursor acute lymphoblastic leukemia in two
Phase 2 studies
Abstract No. 7043, Leukemia, Myelodysplasia,
and Transplantation Poster Session, Sunday,
May 31, 8 a.m. to 11:30 a.m.
CT, S Hall A
- Factors influencing outcomes in patients with
relapsed/refractory B-precursor acute lymphoblastic leukemia
treated with blinatumomab in a Phase 2 study
Abstract No.
7057, Leukemia, Myelodysplasia, and Transplantation Poster Session,
Sunday, May 31, 8 a.m. to 11:30 a.m. CT, S Hall A
- Pharmacokinetics/pharmacodynamics of blinatumomab in
patients with relapsed/refractory B-precursor acute lymphoblastic
leukemia
Abstract No. 2561, Developmental Therapeutics
Poster Session, Saturday, May 30,
8 a.m. to 11:30 a.m. CT, S Hall
A
Key Data in Solid Tumors and Supportive Care:
Prolia® (denosumab)
Results
will be featured from a Phase 3 study evaluating the effects of
denosumab compared with placebo on time to first clinical fracture
in postmenopausal patients with hormone receptor positive breast
cancer receiving aromatase inhibitor (AI) treatment.
- Adjuvant denosumab in breast cancer: results from
3,425 postmenopausal patients of the ABCSG-18 trial
Abstract
No. 504, Breast Cancer Oral Abstract Session, Monday, June 1, 8 a.m. to
11 a.m. CT (Presentation Time: 9:12
a.m. to 9:24 a.m. CT), N Hall B1
Talimogene Laherparepvec
New talimogene laherparepvec
data will be presented from combination studies with checkpoint
inhibitors (anti-PD1 and anti-CTLA4), a neoadjuvant trial in
progress, and additional analyses from the pivotal Phase 3 OPTiM
study in patients with metastatic melanoma.
- Survival, safety, and response patterns in a Phase 1b
multicenter trial of talimogene laherparepvec and ipilimumab in
previously untreated, unresected stage IIIB-IV
melanoma
Abstract No. 9063, Melanoma/Skin Cancers Poster
Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A
- Tumor size and clinical outcomes in melanoma patients
treated with talimogene laherparepvec
Abstract No. 9074,
Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m.
to 4:45 p.m. CT, S Hall A
- A multicenter, open-label trial of talimogene laherparepvec
plus pembrolizumab vs. pembrolizumab monotherapy in previously
untreated, unresected, stage IIIB-IV melanoma (Trials in Progress
abstract)
Abstract No. TPS9081, Melanoma/Skin Cancers Poster
Session, Monday, June 1, 1:15 p.m. to 4:45 p.m. CT, S Hall A
- Phase 2, multicenter, randomized, open-label trial assessing
efficacy and safety of talimogene laherparepvec neoadjuvant
treatment plus surgery vs. surgery for resectable Stage IIIB/C and
IVM1a melanoma (Trials in Progress abstract)
Abstract No.
TPS9094, Melanoma/Skin Cancers Poster Session, Monday, June 1, 1:15 p.m.
to 4:45 p.m. CT, S Hall A
Vectibix® (panitumumab)
In addition to
final results from the Phase 3 ASPECCT study, which investigates
Vectibix compared to cetuximab in wild-type KRAS mCRC,
results from the Phase 2 PEAK study, the Phase 3 PRIME trial and
the Phase 2 '314 study, which examines expression of amphiregulin
and response to first-line Vectibix plus FOLFIRI, will be
presented.
- Final results from ASPECCT: Randomized Phase 3
non-inferiority study of panitumumab vs. cetuximab in
chemorefractory wild-type KRAS exon 2 metastatic colorectal
cancer
Abstract No. 3586, Gastrointestinal (Colorectal)
Cancer Poster Session, Monday, June
1, 8 a.m. to 11:30 a.m. CT, S
Hall A
- Randomized Phase 3 study of panitumumab vs. cetuximab in
chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer:
outcomes by hypomagnesemia in ASPECCT
Abstract No. 3587,
Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to
11:30 a.m. CT, S Hall A
- Tumor response outcomes in first-line treatment of wild-type
RAS metastatic colorectal carcinoma following modified FOLFOX6 +
either panitumumab or bevacizumab
Abstract No. 3535,
Gastrointestinal (Colorectal) Cancer Poster Session, Monday, June 1, 8 a.m. to
11:30 a.m. CT, S Hall A
- The PRIME trial: Quality-adjusted survival in patients with
RAS wild-type metastatic colorectal cancer receiving first-line
therapy with panitumumab plus FOLFOX vs. FOLFOX
alone
Abstract No. 3543, Gastrointestinal (Colorectal)
Cancer Poster Session, Monday, June
1, 8 a.m. to 11:30 a.m. CT, S
Hall A
- Expression of amphiregulin and response to first-line
panitumumab + FOLFIRI in metastatic colorectal cancer
Abstract No. 3536, Gastrointestinal (Colorectal) Cancer Poster
Session, Monday, June 1, 8 a.m. to 11:30 a.m. CT, S Hall A
Neulasta® (pegfilgrastim)
Results from
three studies evaluating the impact of administration and the risk
of febrile neutropenia following myelosuppresive chemotherapy
administration will be published.
- Risk of febrile neutropenia in cancer patients receiving
myelosuppressive chemotherapy and pegfilgrastim prophylaxis: does
day of administration matter? (Publication Only abstract)
- Risk of chemotherapy-induced febrile neutropenia with early
discontinuation of pegfilgrastim prophylaxis in U.S. clinical
practice (Publication Only abstract)
- Effect of timing of pegfilgrastim administration on absolute
neutrophil count trajectory among cancer patients receiving
myelosuppressive chemotherapy (Publication Only abstract)
XGEVA® (denosumab)
An ongoing head-to-head
clinical trial investigating XGEVA compared to zoledronic acid in
patients with multiple myeloma will be presented (study
20090482).
- Denosumab compared with zoledronic acid for the treatment of
bone disease in adults with newly diagnosed multiple myeloma; An
international, randomized, double-blind trial (Trial in Progress
Abstract)
Abstract No. TPS8611, Lymphoma and Plasma Cell
Disorders Poster Session, Sunday, May
31, 8 a.m. to 11:30 a.m. CT, S
Hall A
Amgen Post-ASCO Summary Webcast
Amgen will hold a
post-ASCO summary webcast on Tuesday, June
2 at 1 p.m. CT. Sean E.
Harper, M.D., executive vice president of Research and
Development at Amgen, along with members of Amgen's clinical
development team and clinical investigators will participate to
discuss data presented at ASCO and Amgen's broader oncology
portfolio of products.
Live audio of the event will be simultaneously broadcast over
the Internet and will be available to members of the news media,
investors and the general public.
The webcast, as with other selected presentations regarding
developments in Amgen's business given by management at certain
investor and medical conferences, can be found on Amgen's website,
www.amgen.com, under Investors. Information regarding presentation
times, webcast availability and webcast links are noted on Amgen's
Investor Relations Events Calendar. The webcast will be archived
and available for replay for at least 90 days after the
event.
About Kyprolis® (carfilzomib) for
Injection
On July 20, 2012, the
U.S. FDA granted accelerated approval of Kyprolis 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, thrombotic thrombocytopenic
purpura / hemolytic uremic syndrome (TTP/HUS), posterior reversible
encephalopathy syndrome (PRES), 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.
Cases of thrombotic thrombocytopenic purpura/hemolytic uremic
syndrome (TTP/HUS) including fatal outcome have been reported in
patients who received KYPROLIS.
PRES, formerly termed Reversible Posterior Leukoencephalopathy
Syndrome (RPLS), is a neurological disorder, which can present with
seizure, headache, lethargy, confusion, blindness, altered
consciousness, and other visual and neurological disturbances,
along with hypertension, and the diagnosis is confirmed by
neuro-radiological imaging (MRI). Cases of PRES have been reported
in patients receiving KYPROLIS.
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 BLINCYTO® (blinatumomab)
BLINCYTO is
first FDA-approved bispecific CD19-directed CD3 T-cell engager
(BiTE®) antibody construct product, and the first
single-agent immunotherapy to be approved for the treatment of
patients with Philadelphia
chromosome-negative relapsed or refractory B-cell precursor acute
lymphoblastic leukemia (ALL). Prior to approval, BLINCYTO was
granted breakthrough therapy and priority review designation by the
FDA.
Important U.S. Product Information
BLINCYTO is
indicated for the treatment
of Philadelphia chromosome-negative relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval.
Continued approval for this indication may be contingent upon
verification of clinical benefit in subsequent trials.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving BLINCYTO.
Interrupt or discontinue BLINCYTO as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving BLINCYTO.
Interrupt or discontinue BLINCYTO as recommended.
Contraindications
BLINCYTO is contraindicated in patients with a known
hypersensitivity to blinatumomab or to any component of the product
formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS
occurred in patients receiving BLINCYTO. Infusion reactions have
occurred and may be clinically indistinguishable from
manifestations of CRS. Closely monitor patients for signs and
symptoms of serious events such as pyrexia, headache, nausea,
asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total
bilirubin (TBILI), disseminated intravascular coagulation (DIC),
capillary leak syndrome (CLS), and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Interrupt or discontinue BLINCYTO as outlined in the Prescribing
Information (PI).
- Neurological Toxicities: Approximately 50% of patients
receiving BLINCYTO in clinical trials experienced neurological
toxicities. Severe, life-threatening, or fatal neurological
toxicities occurred in approximately 15% of patients, including
encephalopathy, convulsions, speech disorders, disturbances in
consciousness, confusion and disorientation, and coordination and
balance disorders. The median time to onset of any neurological
toxicity was 7 days. Monitor patients for signs or symptoms and
interrupt or discontinue BLINCYTO as outlined in the PI.
- Infections: Approximately 25% of patients receiving BLINCYTO
experienced serious infections, some of which were life-threatening
or fatal. Administer prophylactic antibiotics and employ
surveillance testing as appropriate during treatment. Monitor
patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO as needed.
- Tumor Lysis Syndrome (TLS): Life-threatening or fatal TLS has
been observed. Preventive measures, including pretreatment nontoxic
cytoreduction and on treatment hydration, should be used during
BLINCYTO treatment. Monitor patients for signs and symptoms of
TLS and interrupt or discontinue BLINCYTO as needed to manage these
events.
- Neutropenia and Febrile Neutropenia, including life-threatening
cases, have been observed. Monitor appropriate laboratory
parameters during BLINCYTO infusion and interrupt BLINCYTO if
prolonged neutropenia occurs.
- Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO® are at risk for loss of
consciousness, and should be advised against driving and engaging
in hazardous occupations or activities such as operating heavy or
potentially dangerous machinery while BLINCYTO® is being
administered.
- Elevated Liver Enzymes: Transient elevations in liver enzymes
are associated with BLINCYTO® treatment. The majority of
these events were observed in the setting of CRS. The median time
to onset was 15 days. Grade 3 or greater elevations in liver
enzymes occurred in 6% of patients outside the setting of CRS and
resulted in treatment discontinuation in less than 1% of
patients. Monitor ALT, AST, gamma-glutamyl transferase (GGT),
and TBILI prior to the start of and during
BLINCYTO® treatment. BLINCYTO treatment should be
interrupted if transaminases rise to > 5 times the upper limit
of normal (ULN) or if TBILI rises to > 3 times ULN.
- Leukoencephalopathy: Although the clinical significance is
unknown, cranial magnetic resonance imaging (MRI) changes showing
leukoencephalopathy have been observed in patients receiving
BLINCYTO®, especially in patients previously
treated with cranial irradiation and anti-leukemic
chemotherapy.
- Preparation and administration errors have occurred. Follow
instructions for preparation (including admixing) and
administration in the PI strictly to minimize medication errors
(including underdose and overdose).
Adverse Events
The most commonly reported adverse
reactions (> 20%) in clinical trials were pyrexia (62%),
headache (36%), peripheral edema (25%), febrile neutropenia (25%),
nausea (25%), hypokalemia (23%), rash (21%), tremor (20%) and
constipation (20%).
Dosage and Administration Guidelines
- BLINCYTO is administered as a continuous intravenous infusion
at a constant flow rate using an infusion pump which should be
programmable, lockable, non-elastomeric, and have an alarm.
- It is very important that the instructions for preparation
(including admixing) and administration provided in the full
Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose).
Please see full Prescribing Information and medication guide for
BLINCYTO® at www.BLINCYTO.com.
About Prolia® (denosumab)
Prolia is the first approved therapy that specifically targets RANK
Ligand, an essential regulator of bone-removing cells
(osteoclasts).
Prolia is approved in the U.S. for the treatment of
postmenopausal women with osteoporosis at high risk for fracture,
defined as a history of osteoporotic fracture, or multiple risk
factors for fracture; or patients who have failed or are intolerant
to other available osteoporosis therapy. Prolia is also approved
for treatment to increase bone mass in men with osteoporosis at
high risk for fracture, defined as a history of osteoporotic
fracture, or multiple risk factors for fracture; or patients who
have failed or are intolerant to other available osteoporosis
therapy.
Prolia is approved in the EU plus Switzerland, Norway, Iceland and Liechtenstein for the treatment of
osteoporosis in postmenopausal women and in men at increased risk
of fractures. Prolia is also approved in the EU for the treatment
of bone loss associated with hormone ablation in men with prostate
cancer at increased risk of fractures.
Prolia is also indicated as a treatment to increase bone mass in
women at high risk for fracture receiving adjuvant aromatase
inhibitor therapy for breast cancer and in men at high risk for
fracture receiving androgen deprivation therapy for nonmetastatic
prostate cancer.
Prolia is administered as a single subcutaneous injection of 60
mg once every six months. Please see the Important Saftey
Information below.
Important Safety Information (U.S.)
Prolia is
contraindicated in patients with hypocalcemia. Preexisting
hypocalcemia must be corrected prior to initiating Prolia. Prolia
is contraindicated in women who are pregnant and may cause fetal
harm. Prolia is contraindicated in patients with a history of
systemic hypersensitivity to any component of the product.
Reactions have included anaphylaxis, facial swelling and urticaria.
Prolia contains the same active ingredient (denosumab) found in
XGEVA®. Patients receiving Prolia should not receive
XGEVA.
Clinically significant hypersensitivity including anaphylaxis
has been reported with Prolia. Symptoms have included hypotension,
dyspnea, throat tightness, facial and upper airway edema, pruritus,
and urticaria. If an anaphylactic or other clinically significant
allergic reaction occurs, initiate appropriate therapy and
discontinue further use of Prolia. Hypocalcemia may worsen in
patients taking Prolia, especially in patients with severe renal
impairment. In patients predisposed to hypocalcemia and
disturbances of mineral metabolism, clinical monitoring of calcium
and mineral levels is highly recommended within 14 days of Prolia
injection. Adequately supplement all patients with calcium and
vitamin D.
Osteonecrosis of the jaw (ONJ), which can occur spontaneously,
is generally associated with tooth extraction and/or local
infection with delayed healing and has been reported in patients
receiving Prolia. A routine oral exam should be performed by the
prescriber prior to initiation of Prolia. A dental examination with
appropriate preventive dentistry is recommended prior to treatment
with Prolia in patients with risk factors for ONJ such as invasive
dental procedures, diagnosis of cancer, concomitant therapies
(e.g., chemotherapy, corticosteroids, angiogenesis inhibitors),
poor oral hygiene, and co-morbid disorders. Good oral hygiene
practices should be maintained during treatment. For patients
requiring invasive dental procedures, clinical judgment should
guide the management plan of each patient. Patients who are
suspected of having or who develop ONJ should receive care by a
dentist or an oral surgeon. Extensive dental surgery to treat ONJ
may exacerbate the condition. Discontinuation of Prolia therapy
should be considered based on individual benefit-risk
assessment.
Atypical low-energy or low trauma fractures of the shaft have
been reported in patients receiving Prolia. Causality has not been
established as these fractures also occur in osteoporotic patients
who have not been treated with antiresorptive agents. During Prolia
treatment, patients should be advised to report new or unusual
thigh, hip, or groin pain. Any patient who presents with thigh or
groin pain should be evaluated to rule out an incomplete femur
fracture. Interruption of Prolia therapy should be considered,
pending a risk/benefit assessment, on an individual basis.
In a clinical trial (N= 7800) in women with postmenopausal
osteoporosis, serious infections leading to hospitalization were
reported more frequently in the Prolia group than in the placebo
group. Serious skin infections, as well as infections of the
abdomen, urinary tract and ear were more frequent in patients
treated with Prolia. Endocarditis was also reported more frequently
in Prolia-treated patients. The incidence of opportunistic
infections and the overall incidence of infections were similar
between the treatment groups. Advise patients to seek prompt
medical attention if they develop signs or symptoms of severe
infection, including cellulitis. Patients on concomitant
immunosuppressant agents or with impaired immune systems may be at
increased risk for serious infections. In patients who develop
serious infections while on Prolia, prescribers should assess the
need for continued Prolia therapy.
In the same clinical trial in women with postmenopausal
osteoporosis, epidermal and dermal adverse events such as
dermatitis, eczema and rashes occurred at a significantly higher
rate with Prolia compared to placebo. Most of these events were not
specific to the injection site. Consider discontinuing Prolia if
severe symptoms develop.
Severe and occasionally incapacitating bone, joint, and/or
muscle pain has been reported in patients taking Prolia. Consider
discontinuing use if severe symptoms develop. Suppression of
Bone Turnover In clinical trials in women with postmenopausal
osteoporosis, Prolia resulted in significant suppression of bone
remodeling as evidenced by markers of bone turnover and bone
histomorphometry. The significance of these findings and the effect
of long-term treatment are unknown. Monitor patients for these
consequences, including ONJ, atypical fractures, and delayed
fracture healing.
It is not known whether Prolia is excreted into human milk.
Measurable concentrations of denosumab were present in the maternal
milk of cynomolgus monkeys up to 1 month after the last dose of
denosumab (≤ 0.5% milk:serum ratio). Because many drugs are
excreted in human milk and because of the potential for serious
adverse reactions in nursing infants from Prolia®, a decision
should be made whether to discontinue nursing or discontinue the
drug, taking into account the importance of the drug to the
mother.
The most common adverse reactions (>5% and more common than
placebo) in women with postmenopausal osteoporosis are back pain,
pain in extremity, musculoskeletal pain, hypercholesterolemia, and
cystitis. The most common adverse reactions (> 5% and more
common than placebo) in men with osteoporosis are back pain,
arthralgia, and nasopharyngitis. Pancreatitis has been reported
with Prolia. In women with postmenopausal osteoporosis, the overall
incidence of new malignancies was 4.3% in the placebo group and
4.8% in the Prolia groups. In men with osteoporosis, new
malignancies were reported in no patients in the placebo group and
4 (3.3%) patients in the Prolia group. A causal relationship to
drug exposure has not been established. Denosumab is a human
monoclonal antibody. As with all therapeutic proteins, there is
potential for immunogenicity. The most common (per patient
incidence ≥ 10%) adverse reactions reported with Prolia in patients
with bone loss receiving ADT for prostate cancer or adjuvant AI
therapy for breast cancer are arthralgia and back pain. Pain in
extremity and musculoskeletal pain have also been reported in
clinical trials. Additionally, in Proliatreated men with
nonmetastatic prostate cancer receiving ADT, a greater incidence of
cataracts was observed.
For more information, please see the Prolia Important Safety
Information, Prescribing Information, and Medication Guide.
The Prolia Postmarketing Active Safety Surveillance Program is
available to collect information from prescribers on specific
adverse events. Please see www.proliasafety.com or call
18007726436 for more information
About Talimogene Laherparepvec
Talimogene
laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumors (but not normal tissue)
and to initiate an immune response to target cancer cells that have
metastasized. Talimogene laherparepvec was designed to work in two
important and complementary ways. First, it is injected directly
into tumors where it replicates inside the tumor's cells causing
the cell to rupture and die in a process called lysis. The rupture
of the cancer cells can release tumor-derived antigens, along with
GM-CSF, that can stimulate a system-wide immune response where
white blood cells are able to seek out and target cancer that has
spread throughout the body.
About Vectibix® (panitumumab)
Vectibix is
a fully human anti-EGFR antibody. Vectibix is approved by the FDA
for use in patients with wild-type KRAS (exon 2) mCRC in
combination with FOLFOX as first-line treatment and as a
monotherapy after disease progression after prior treatment with
fluoropyrimidine-, oxaliplatin-, and irinotecan-containing
chemotherapy. Vectibix is the first and only biologic therapy
indicated for use with FOLFOX, one of the most commonly used
chemotherapy regimens, in the first-line treatment of mCRC for
patients with wild-type KRAS mCRC.
Important U.S. Product Information
Vectibix is
indicated for the treatment of patients with
wild-type KRAS (exon 2 in codons 12 or 13)
metastatic colorectal cancer (mCRC) as determined by
an FDA-approved test for this use:
- As first-line therapy in combination with FOLFOX
- As monotherapy following disease progression after prior
treatment with fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy
Limitation of Use: Vectibix is not indicated for the treatment
of patients with RAS-mutant mCRC or for
whom RAS mutation status is unknown.
WARNING: DERMATOLOGIC TOXICITY
Dermatologic
Toxicity: Dermatologic toxicities occurred in 90 percent of
patients and were severe (NCI-CTC grade 3 or higher) in 15% of
patients receiving Vectibix monotherapy.
Vectibix is not indicated for the treatment of patients with
colorectal cancer that harbor somatic mutations in exon 2 (codons
12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and
146) of eitherKRAS or NRAS and
hereafter is referred to as "RAS".
Retrospective subset analyses across several randomized clinical
trials were conducted to investigate the role
of RAS mutations on the clinical effects of
anti-EGFR-directed monoclonal antibodies (panitumumab or
cetuximab). Anti-EGFR antibodies in patients with tumors
containing RAS mutations resulted in exposing
those patients to anti-EGFR related adverse reactions without
clinical benefit from these agents.
Additionally, in Study 3, 272 patients
with RAS-mutant mCRC tumors received Vectibix in
combination with FOLFOX and 276 patients received FOLFOX alone. In
an exploratory subgroup analysis, OS was shorter (HR = 1.21, 95% CI
1.01-1.45) in patients with RAS-mutant mCRC who
received Vectibix and FOLFOX versus FOLFOX alone.
Progressively decreasing serum magnesium levels leading to
severe (Grade 3-4) hypomagnesemia occurred in up to 7% (in Study 2)
of patients across clinical trials. Monitor patients for
hypomagnesemia and hypocalcemia prior to initiating Vectibix
treatment, periodically during Vectibix treatment, and for up to 8
weeks after the completion of treatment.
In Study 1, 4% of patients experienced infusion reactions and 1%
of patients experienced severe infusion reactions (NCI-CTC grade
3-4).
Severe diarrhea and dehydration, leading to acute renal failure
and other complications, have been observed in patients treated
with Vectibix in combination with chemotherapy.
Fatal and non-fatal cases of interstitial lung disease (ILD)
(1%) and pulmonary fibrosis have been observed in patients treated
with Vectibix. Pulmonary fibrosis occurred in less than 1% (2/1467)
of patients enrolled in clinical studies of Vectibix. In the event
of acute onset or worsening of pulmonary symptoms, interrupt
Vectibix therapy. Discontinue Vectibix therapy if ILD is
confirmed.
Adverse Reactions
The most common adverse reactions
(> 20%) of Vectibix are skin rash with variable presentations,
paronychia, fatigue, nausea and diarrhea. The most frequently
reported adverse reactions for Vectibix leading to withdrawal were
general physical health deterioration and intestinal
obstruction.
The most commonly reported adverse reactions (≥ 20%) in patients
with wild-type KRAS mCRC receiving Vectibix (6
mg/kg every 2 weeks) and FOLFOX therapy (N = 322) in Study 3 were
diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia,
anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis,
pruritus, and dry skin. Serious adverse reactions (≥ 2%
difference between treatment arms) in Vectibix-treated patients
with wild-type KRAS mCRC were diarrhea and
dehydration.
To see the full Vectibix Safety Information,
visit www.vectibix.com.
About Neulasta® (pegfilgrastim)
Neulasta is
a leukocyte growth factor approved by the FDA in 2002, and is
indicated to decrease the incidence of infection, as manifested by
febrile neutropenia, in patients with nonmyeloid malignancies
receiving myelosuppressive anticancer drugs associated with a
clinically significant incidence of febrile neutropenia. Neulasta
is not indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem cell transplantation.
In a pivotal clinical trial, in patients with nonmyeloid
malignancies undergoing myelosuppressive chemotherapy associated
with a clinically significant incidence of febrile neutropenia,
treatment with Neulasta has been shown to significantly reduce the
incidence of febrile neutropenia as well as hospitalizations
related to febrile neutropenia and the use of IV
antibiotics.1
For more information about Neulasta, visit www.Neulasta.com and
www.NeulastaHCP.com.
Important Safety Information
Contraindication
Do not administer Neulasta to
patients with a history of serious allergic reactions to
pegfilgrastim or filgrastim.
Splenic Rupture
Splenic rupture, including fatal
cases, can occur following the administration of Neulasta. Evaluate
for an enlarged spleen or splenic rupture in patients who report
left upper abdominal or shoulder pain after receiving Neulasta.
Acute Respiratory Distress Syndrome
Acute respiratory
distress syndrome (ARDS) can occur in patients receiving
Neulasta. Evaluate patients who develop fever and lung infiltrates
or respiratory distress after receiving Neulasta for ARDS.
Discontinue Neulasta in patients with ARDS.
Serious Allergic Reactions
Serious allergic reactions,
including anaphylaxis, can occur in patients receiving Neulasta.
The majority of reported events occurred upon initial exposure.
Allergic reactions, including anaphylaxis, can recur within days
after the discontinuation of initial anti-allergic treatment.
Permanently discontinue Neulasta in patients with serious allergic
reactions.
Allergies to Acrylics
The On-body Injector for
Neulasta uses acrylic adhesive. For patients who have reactions to
acrylic adhesives, use of this product may result in a significant
reaction.
Use in Patients With Sickle Cell Disorders
Severe
sickle cell crises can occur in patients with sickle cell disorders
receiving Neulasta. Severe and sometimes fatal sickle cell crises
can occur in patients with sickle cell disorders receiving
filgrastim, the parent compound of pegfilgrastim.
Potential for Tumor Growth Stimulatory Effects on Malignant
Cells
The granulocyte colony-stimulating factor (G-CSF)
receptor, through which pegfilgrastim and filgrastim act, has been
found on tumor cell lines. The possibility that pegfilgrastim acts
as a growth factor for any tumor type, including myeloid
malignancies and myelodysplasia, diseases for which pegfilgrastim
is not approved, cannot be excluded.
The most common adverse reactions (≥ 5% difference in incidence)
in placebo-controlled clinical trials are bone pain and pain in
extremity.
Please see additional Neulasta Safety Information, by visiting
www.amgen.com/medpro/products.html.
Please see the Neulasta Full Prescribing Information by clicking
here
http://pi.amgen.com/united_states/neulasta/neulasta_pi_hcp_english.pdf.
About XGEVA® (denosumab)
XGEVA was approved
by the FDA in 2010 for the prevention of skeletal-related events
(SREs) in patients with bone metastases from solid tumors (XGEVA is
not indicated for the prevention of SREs in patients with multiple
myeloma).
In clinical trials, XGEVA demonstrated a clinically meaningful
improvement compared to zoledronic acid (the previous standard of
care) in preventing SREs, such as clinical fractures, surgery to
the bone, spinal cord compression or radiation. XGEVA is
administered as a single subcutaneous injection of 120 mg once
every 4 weeks.
In 2013, XGEVA was approved by the FDA as the first-and-only
treatment for adults and skeletally mature adolescents with giant
cell tumor of bone that is unresectable or where surgical resection
is likely to result in severe morbidity.
In 2014, XGEVA was approved by the FDA for the treatment of
hypercalcemia of malignancy refractory to bisphosphonate
therapy.
Important Safety Information
Hypocalcemia
Pre-existing hypocalcemia must be
corrected prior to initiating therapy with XGEVA. XGEVA can cause
severe symptomatic hypocalcemia, and fatal cases have been
reported. Monitor calcium levels and administer calcium, magnesium,
and vitamin D as necessary. Monitor levels more frequently when
XGEVA is administered with other drugs that can also lower calcium
levels. Advise patients to contact a healthcare professional for
symptoms of hypocalcemia.
Hypersensitivity
XGEVA is contraindicated in patients
with known clinically significant hypersensitivity to
XGEVA, including anaphylaxis that has been reported
with use of XGEVA. If an anaphylactic or other clinically
significant allergic reaction occurs, initiate appropriate therapy
and discontinue XGEVA therapy permanently.
Drug Products with Same Active Ingredient
Patients
receiving XGEVA should not take
Prolia® (denosumab).
Osteonecrosis of the Jaw
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. In clinical trials in patients with osseous
metastasis, the incidence of ONJ was higher with longer duration of
exposure.
Atypical Subtrochanteric and Diaphyseal Femoral
Fracture
Atypical femoral fracture has been reported with
XGEVA. These fractures can occur anywhere in the femoral shaft from
just below the lesser trochanter to above the supracondylar flare
and are transverse or short oblique in orientation without evidence
of comminution.
Atypical femoral fractures most commonly occur with minimal or
no trauma to the affected area. During XGEVA treatment, patients
should be advised to report new or unusual thigh, hip, or groin
pain. Patient presenting with an atypical femur fracture should
also be assessed for symptoms and signs of fracture in the
contralateral limb. Interruption of XGEVA therapy should be
considered, pending a risk/benefit assessment, on an individual
basis.
Embryo-Fetal Toxicity
XGEVA can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to use highly effective contraception during therapy, and
for at least five months after the last dose of
XGEVA.
Adverse Reactions
The most common adverse reactions in
patients receiving XGEVA with bone metastasis from solid tumors
were fatigue/asthenia, hypophosphatemia, and nausea. The most
common serious adverse reaction was dyspnea.
The most common adverse reactions in patients receiving XGEVA
for giant cell tumor of bone were arthralgia, headache, nausea,
back pain, fatigue, and pain in extremity. The most common serious
adverse reactions were osteonecrosis of the jaw and osteomyelitis.
The most common adverse reactions resulting in discontinuation of
XGEVA were osteonecrosis of the jaw and tooth abscess or tooth
infection.
The most common adverse reactions in patients receiving XGEVA
for hypercalcemia of malignancy were nausea, dyspnea, decreased
appetite, headache, peripheral edema, vomiting, anemia,
constipation, and diarrhea.
Denosumab is also marketed as Prolia® in other
indications.
Please visit www.amgen.com or www.xgeva.com for
Full Prescribing Information.
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
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forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen,
we or us) 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 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 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 May 13, 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 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
and our partners to complete clinical trials and obtain regulatory
approval for product marketing has in the past varied and we expect
similar variability in the future. We develop product candidates
internally and through licensing collaborations, partnerships and
joint ventures. Product candidates that are derived from
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prove to be not as effective or as safe as we may have believed at
the time of entering into such relationship. Also, we or others
could identify safety, side effects or manufacturing problems with
our products after they are on the market. Our business may be
impacted by government investigations, litigation and product
liability claims. If we fail to meet the compliance obligations in
the corporate integrity agreement between us and the U.S.
government, we could become subject to significant sanctions. We
depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products (including products of our
wholly-owned subsidiaries) are affected by the reimbursement
policies imposed by third-party payers, including governments,
private insurance plans and managed care providers and may be
affected by regulatory, clinical and guideline developments and
domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we and
our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
and patent applications may be challenged, invalidated or
circumvented by our or our partners' competitors and there can be
no guarantee of our or our partners' ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our recently
announced restructuring plan. Our business performance could affect
or limit the ability of our Board of Directors to declare a
dividend or our ability to pay a dividend or repurchase common
stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and
investigative. Such product candidates are not approved by
the U.S. Food and Drug Administration (FDA), and no conclusions can
or should be drawn regarding the safety or effectiveness of the
product candidates. Further, the scientific information
discussed in this news release relating to new indications for our
products is preliminary and investigative and is not part of the
labeling approved by the FDA for the products. The products
are not approved for the investigational use(s) discussed in
this news release, and no conclusions can or should be drawn
regarding the safety or effectiveness of the products for
these uses.
Velcade® is a registered trademark of Millennium
Pharmaceuticals, Inc.
CONTACT:
Amgen, Thousand Oaks
Cuyler Mayer, 805-447-6332
(media)
Arvind Sood, 805-447-1060
(investors)
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