THOUSAND OAKS, Calif.,
May 18, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that new clinical data from across
the oncology portfolio, including Kyprolis®
(carfilzomib), IMLYGIC® (talimogene laherparepvec),
Vectibix® (panitumumab) and Neulasta®
(pegfilgrastim) will be presented at the 52nd Annual
Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, June 3-7, 2016.
"As a leader in patient-focused oncology research, Amgen is
committed to translating innovative science into treatments that
make a difference in the lives of people suffering from cancer,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "The breadth
and depth of data we're presenting at ASCO demonstrates our
commitment to finding solutions to some of the toughest cancers. We
are thankful for our research partners who help us achieve this
mission, and we look forward to sharing these results at ASCO."
Amongst the Kyprolis abstracts to be presented at the meeting
will be a new subgroup analysis from the Phase 3 ASPIRE trial which
compared Kyprolis in combination with lenalidomide and
dexamethasone versus lenalidomide and dexamethasone alone in
relapsed multiple myeloma patients who had early disease
progression following prior therapy (including transplant).
Presentations highlighting Kyprolis data include:
- Carfilzomib, Lenalidomide, and Dexamethasone (KRd) vs.
Lenalidomide and Dexamethasone (Rd) in Patients with Relapsed
Multiple Myeloma (RMM) and Early Progression During Prior Therapy:
Secondary Analysis From the Phase 3 Study ASPIRE
(NCT01080391)
Abstract #8045, Poster, Monday, June 6 at 8 a.m.
CDT in McCormick Place, Hall A
- Risk of Hypertension (HTN) and Malignant Hypertension (mHTN)
in Patients Treated for Multiple Myeloma (MM)
Abstract
#8049, Poster, Monday, June 6 at
8 a.m. CDT in McCormick Place, Hall
A
- Transitions Across Different Lines of Therapy in the
Medicare-Enrolled Patient Population with Multiple
Myeloma
Abstract #8043, Poster, Monday, June 6 at 8 a.m.
CDT in McCormick Place, Hall A
- Treatment Regimens and Duration of Lines of Therapy in
Medicare-Enrolled Patients with Multiple Myeloma
Abstract
#8046, Poster, Monday, June 6 at
8 a.m. CDT in McCormick Place, Hall
A
- Costs Associated With Treatment Induced Peripheral
Neuropathy in Patients with Multiple Myeloma (MM)
Abstract
#8048, Poster, Monday, June 6 at
8 a.m. CDT in McCormick Place, Hall
A
- Healthcare Costs Among Multiple Myeloma (MM) Patients (Pts)
without Stem Cell Transplant (SCT)
Abstract #8059, Poster,
Monday, June 6 at 8 a.m. CDT in McCormick Place, Hall A
- Retrospective Study of Frequency and Cost of Multiple
Myeloma (MM) Complications and Treatment (Tx) Related Adverse
Events (AEs)
Abstract #8060, Poster, Monday, June 6 at 8 a.m.
CDT in McCormick Place, Hall A
- Economic Evaluation of Carfilzomib + Lenalidomide +
Dexamethasone (KRd) vs. Lenalidomide + Dexamethasone (Rd) in
Relapsed or Refractory Multiple Myeloma (R/RMM)
Abstract
#8021, Poster Discussion, Monday, June
6 at 3 p.m. CDT in McCormick
Place, E354b
Two abstracts on the MASTERKEY-265 trial of IMLYGIC in
combination with pembrolizumab in patients with unresectable Stage
IIIB-IV melanoma will be presented:
- Efficacy Analysis of MASTERKEY-265 Phase 1b Study of
Talimogene Laherparepvec (T-VEC) and Pembrolizumab (Pembro) for
Unresectable Stage IIIB‑IV Melanoma
Abstract #9568, Poster
Presentation, Saturday, June 4 from
1-4:30 p.m. CDT in McCormick Place,
Hall A
- A Phase 1/3, Multicenter Trial of Talimogene Laherparepvec
in Combination with Pembrolizumab for Unresected, Stage IIIB-IV
Melanoma (MASTERKEY-265)
Abstract #TPS9598, Poster
Presentation, Saturday, June 4 from
1-4:30 p.m. CDT in McCormick Place,
Hall A
Key data from two abstracts and one publication will be
presented on Vectibix, including the final results from a Phase 3
trial of Vectibix and best supportive care (BSC) versus BSC in
chemorefractory wild-type KRAS exon 2 and wild-type
RAS metastatic colorectal cancer (mCRC):
- Association of ECOG Performance Status with Efficacy in
Patients Receiving Panitumumab with Best Supportive Care (BSC) vs.
BSC Alone for Chemorefractory Metastatic Colorectal Cancer
Publication only
- Final Results from a Phase 3 Trial Evaluating Panitumumab
(pmab) + Best Supportive Care (BSC) vs. BSC in Chemorefractory
Wild-type (WT) KRAS Exon 2 and WT RAS Metastatic
Colorectal Cancer (mCRC)
Abstract #3536, Poster,
Saturday, June 4 at 8 a.m. CDT in McCormick Place, Hall A
- Efficacy of Panitumumab vs. Cetuximab in
Patients with Wild-type KRAS Exon 2 Metastatic
Colorectal Cancer Treated with Prior Bevacizumab: Results from
ASPECCT
Abstract #3538, Poster, Saturday, June 4 at 8 a.m.
CDT in McCormick Place, Hall A
Three abstracts will be presented on Neulasta and
NEUPOGEN® (filgrastim), providing new insights into
their role in supportive care, including:
- NOLAN: A Randomized, Phase 2 Study to Estimate the Effect of
Prophylactic Naproxen (N) or Loratadine (L) vs. No Intervention on
Bone Pain in 600 Patients (pts) with Early-Stage Breast Cancer
Receiving Chemotherapy (chemo) and Pegfilgrastim
(PEG)
Abstract #10021, Poster Discussion, Monday, June 6 at 4:45
p.m. CDT in McCormick Place, S102
- Burden of Febrile Neutropenia Hospitalizations (FNH) in U.S.
Clinical Practice, by Use and Patterns of Colony-Stimulating Factor
Prophylaxis (CP)
Abstract #6568, Poster, Saturday, June 4 at 1 p.m.
CDT in McCormick Place, Hall A
- Risk Factors for Febrile Neutropenia in Cancer Patients
Treated With Chemotherapy
Abstract #6559, Poster,
Saturday, June 4 at 1 p.m. CDT in McCormick Place, Hall A
One abstract will be presented on investigational agent ABP 215,
which is being developed as a biosimilar to bevacizumab:
- Randomized, Double-Blind, Phase 3 Study Evaluating Efficacy
and Safety of ABP 215 Compared with Bevacizumab in Patients with
Non-Squamous NSCLC
Abstract #9095, Poster Presentation,
Saturday, June 4, at 8 a.m. CDT in McCormick Place, Hall A
Abstracts are currently available on the ASCO website.
About Kyprolis® (carfilzomib)
Proteasomes play an important role in cell function and growth by
breaking down proteins that are damaged or no longer
needed.1 Kyprolis has been shown to block proteasomes,
leading to an excessive build-up of proteins within
cells.2 In some cells, Kyprolis can cause cell death,
especially in myeloma cells because they are more likely to contain
a higher amount of abnormal proteins.2 The
irreversibility of Kyprolis' binding has also been shown to offer a
more sustained inhibition of the targeted enzymes.3
Kyprolis is approved in the U.S. for the following:
- In combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- As a single agent for the treatment of patients with relapsed
or refractory multiple myeloma who have received one or more lines
of therapy.
Kyprolis is also approved in Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada and the European Union. Additional
regulatory applications for Kyprolis are underway and have been
submitted to health authorities worldwide.
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, please visit www.kyprolis.com.
Important Safety Information Regarding
Kyprolis® (carfilzomib) for Injection
INDICATION(S)
- KYPROLIS® (carfilzomib) is indicated in
combination with dexamethasone or with lenalidomide plus
dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma who have received one to three lines of
therapy.
- KYPROLIS® (carfilzomib) is indicated as a
single agent for the treatment of patients with relapsed or
refractory multiple myeloma who have received one or more lines of
therapy.
IMPORTANT SAFETY INFORMATION
Cardiac Toxicities
- New onset or worsening of pre-existing cardiac failure (e.g.,
congestive heart failure, pulmonary edema, decreased ejection
fraction), restrictive cardiomyopathy, myocardial ischemia, and
myocardial infarction including fatalities have occurred following
administration of KYPROLIS. Some events occurred in patients with
normal baseline ventricular function. Death due to cardiac arrest
has occurred within one day of KYPROLIS administration.
- Monitor patients for clinical signs or symptoms of cardiac
failure or cardiac ischemia. Evaluate promptly if cardiac toxicity
is suspected. Withhold KYPROLIS for Grade 3 or 4 cardiac adverse
events until recovery, and consider whether to restart KYPROLIS at
1 dose level reduction based on a benefit/risk assessment.
- While adequate hydration is required prior to each dose in
Cycle 1, monitor all patients for evidence of volume overload,
especially patients at risk for cardiac failure. Adjust total fluid
intake as clinically appropriate in patients with baseline cardiac
failure or who are at risk for cardiac failure.
- In Patients > 75 years, the risk of cardiac
failure is increased. Patients with New York Heart Association
Class III and IV heart failure, recent myocardial infarction,
conduction abnormalities, angina, or arrhythmias may be at greater
risk for cardiac complications and should have a comprehensive
medical assessment (including blood pressure and fluid management)
prior to starting treatment with KYPROLIS and remain under close
follow-up.
Acute Renal Failure
- Cases of acute renal failure and renal insufficiency adverse
events (including renal failure) have occurred in patients
receiving KYPROLIS. Acute renal failure was reported more
frequently in patients with advanced relapsed and refractory
multiple myeloma who received KYPROLIS monotherapy. Monitor renal
function with regular measurement of the serum creatinine and/or
estimated creatinine clearance. Reduce or withhold dose as
appropriate.
Tumor Lysis Syndrome
- Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes,
have occurred in patients receiving KYPROLIS. Patients with
multiple myeloma and a high tumor burden should be considered at
greater risk for TLS. Adequate hydration is required prior to each
dose in Cycle 1, and in subsequent cycles as needed. Consider uric
acid lowering drugs in patients at risk for TLS. Monitor for
evidence of TLS during treatment and manage promptly. Withhold
KYPROLIS until TLS is resolved.
Pulmonary Toxicity
- Acute Respiratory Distress Syndrome (ARDS), acute respiratory
failure, and acute diffuse infiltrative pulmonary disease such as
pneumonitis and interstitial lung disease have occurred in patients
receiving KYPROLIS. Some events have been fatal. In the event
of drug-induced pulmonary toxicity, discontinue
KYPROLIS.
Pulmonary Hypertension
- Pulmonary arterial hypertension (PAH) was reported in patients
treated with KYPROLIS. Evaluate with cardiac imaging and/or other
tests as indicated. Withhold KYPROLIS for PAH until resolved or
returned to baseline and consider whether to restart KYPROLIS based
on a benefit/risk assessment.
Dyspnea
- Dyspnea was reported in patients treated with KYPROLIS.
Evaluate dyspnea to exclude cardiopulmonary conditions including
cardiac failure and pulmonary syndromes. Stop KYPROLIS for Grade 3
or 4 dyspnea until resolved or returned to baseline. Consider
whether to restart KYPROLIS based on a benefit/risk
assessment.
Hypertension
- Hypertension, including hypertensive crisis and hypertensive
emergency, has been observed with KYPROLIS. Some of these events
have been fatal. Monitor blood pressure regularly in all patients.
If hypertension cannot be adequately controlled, withhold KYPROLIS
and evaluate. Consider whether to restart KYPROLIS based on a
benefit/risk assessment.
Venous Thrombosis
- Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed with KYPROLIS.
Thromboprophylaxis is recommended for patients being treated with
the combination of KYPROLIS with dexamethasone or with lenalidomide
plus dexamethasone. The thromboprophylaxis regimen should be based
on an assessment of the patient's underlying risks.
- Patients using oral contraceptives or a hormonal method of
contraception associated with a risk of thrombosis should consider
an alternative method of effective contraception during treatment
with KYPROLIS in combination with dexamethasone or lenalidomide
plus dexamethasone.
Infusion Reactions
- Infusion reactions,
including life-threatening reactions, have occurred in
patients receiving KYPROLIS. Symptoms include fever, chills,
arthralgia, myalgia, facial flushing, facial edema, vomiting,
weakness, shortness of breath, hypotension, syncope, chest
tightness, or angina. These reactions can occur immediately
following or up to 24 hours after administration of KYPROLIS.
Premedicate with dexamethasone to reduce the incidence and severity
of infusion reactions. Inform patients of the risk and of symptoms
of an infusion reaction and to contact a physician immediately if
they occur.
Thrombocytopenia
- KYPROLIS causes thrombocytopenia with recovery to baseline
platelet count usually by the start of the next cycle.
Thrombocytopenia was reported in patients receiving KYPROLIS.
Monitor platelet counts frequently during treatment with KYPROLIS.
Reduce or withhold dose as appropriate.
Hepatic Toxicity and Hepatic Failure
- Cases of hepatic failure, including fatal cases, have been
reported during treatment with KYPROLIS. KYPROLIS can cause
increased serum transaminases. Monitor liver enzymes regularly
regardless of baseline values. Reduce or withhold dose as
appropriate.
Thrombotic Microangiopathy
- Cases of thrombotic microangiopathy, including thrombotic
thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS),
including fatal outcome have occurred in patients receiving
KYPROLIS. Monitor for signs and symptoms of TTP/HUS. Discontinue
KYPROLIS if diagnosis is suspected. If the diagnosis of TTP/HUS is
excluded, KYPROLIS may be restarted. The safety of reinitiating
KYPROLIS therapy in patients previously experiencing TTP/HUS is not
known.
Posterior Reversible Encephalopathy Syndrome (PRES)
- Cases of PRES have occurred in patients receiving KYPROLIS.
PRES was formerly known as Reversible Posterior Leukoencephalopathy
Syndrome. Consider a neuroradiological imaging (MRI) for onset of
visual or neurological symptoms. Discontinue KYPROLIS if PRES is
suspected and evaluate. The safety of reinitiating KYPROLIS therapy
in patients previously experiencing PRES is not known.
Embryo-fetal Toxicity
- KYPROLIS can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings in
animals.
- Females of reproductive potential should be advised to avoid
becoming pregnant while being treated with KYPROLIS. Males of
reproductive potential should be advised to avoid fathering a child
while being treated with KYPROLIS. If this drug is used during
pregnancy, or if pregnancy occurs while taking this drug, the
patient should be apprised of the potential hazard to the
fetus.
ADVERSE REACTIONS
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in the combination therapy trials:
anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia,
pyrexia, insomnia, muscle spasm, cough, upper respiratory tract
infection, hypokalemia.
- The most common adverse events occurring in at least 20% of
patients treated with KYPROLIS in monotherapy trials: anemia,
fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea,
headache, cough, edema peripheral.
Please see full Prescribing Information
at www.kyprolis.com.
About IMLYGIC™ (talimogene laherparepvec)
IMLYGIC is a genetically modified herpes simplex type 1 virus that
is injected directly into tumors. IMLYGIC replicates inside tumor
cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC
then causes the cell to rupture and die in a process called lysis.
The rupture of the cancer cells causes the release of tumor-derived
antigens, which together with virally derived GM-CSF may help to
promote an anti-tumor immune response. However, the exact mechanism
of action is unknown.
IMLYGIC is the first oncolytic viral therapy approved by the
U.S. Food and Drug Administration (FDA) based on
therapeutic benefit demonstrated in a pivotal study. IMLYGIC is a
genetically modified oncolytic viral therapy indicated for the
local treatment of unresectable cutaneous, subcutaneous, and nodal
lesions in patients with melanoma recurrent after initial surgery.
IMLYGIC has not been shown to improve overall survival or have an
effect on visceral metastases.
Important Safety Information
Contraindications
- Do not administer IMLYGIC™ to immunocompromised patients,
including those with a history of primary or acquired
immunodeficient states, leukemia, lymphoma, AIDS or other clinical
manifestations of infection with human immunodeficiency viruses,
and those on immunosuppressive therapy, due to the risk of
life-threatening disseminated herpetic infection.
- Do not administer IMLYGIC™ to pregnant patients.
Warnings and Precautions
- Accidental exposure to IMLYGIC™ may lead to
transmission of IMLYGIC™ and herpetic infection, including during
preparation and administration. Health care providers, close
contacts, pregnant women, and newborns should avoid direct contact
with injected lesions, dressings, or body fluids of treated
patients. The affected area in exposed individuals should be
cleaned thoroughly with soap and water and/or a disinfectant.
- Caregivers should wear protective gloves when assisting
patients in applying or changing occlusive dressings and observe
safety precautions for disposal of used dressings, gloves, and
cleaning materials. Exposed individuals should clean the affected
area thoroughly with soap and water and/or a disinfectant.
- To prevent possible inadvertent transfer of IMLYGIC™ to other
areas of the body, patients should be advised to avoid touching or
scratching injection sites or occlusive dressings.
- Herpetic infections: Herpetic infections (including
cold sores and herpetic keratitis) have been reported in
IMLYGIC™-treated patients. Disseminated herpetic infection may also
occur in immunocompromised patients. Patients who develop
suspicious herpes-like lesions should follow standard hygienic
practices to prevent viral transmission.
- Patients or close contacts with suspected signs or symptoms of
a herpetic infection should contact their health care provider to
evaluate the lesions. Suspected herpetic lesions should be reported
to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or
close contacts have the option of follow-up testing for further
characterization of the infection.
- IMLYGIC™ is sensitive to acyclovir. Acyclovir or other
antiviral agents may interfere with the effectiveness of IMLYGIC™.
Consider the risks and benefits of IMLYGIC™ treatment before
administering antiviral agents to manage herpetic infection.
- Injection Site Complications: Necrosis or
ulceration of tumor tissue may occur during IMLYGIC™ treatment.
Cellulitis and systemic bacterial infection have been reported in
clinical studies. Careful wound care and infection precautions are
recommended, particularly if tissue necrosis results in open
wounds.
- Impaired healing at the injection site has been reported.
IMLYGIC™ may increase the risk of impaired healing in patients with
underlying risk factors (e.g., previous radiation at the injection
site or lesions in poorly vascularized areas). If there is
persistent infection or delayed healing of the injection site,
consider the risks and benefits of continuing treatment.
- Immune-Mediated events including
glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis,
and vitiligo have been reported in patients treated with IMLYGIC™.
Consider the risks and benefits of IMLYGIC™ before initiating
treatment in patients who have underlying autoimmune disease or
before continuing treatment in patients who develop immune-mediated
events.
- Plasmacytoma at Injection Site: Plasmacytoma in
proximity to the injection site has been reported in a patient with
smoldering multiple myeloma after IMLYGIC™ administration in a
clinical study. Consider the risks and benefits of IMLYGIC™ in
patients with multiple myeloma or in whom plasmacytoma develops
during treatment.
Adverse Reactions
- The most commonly reported adverse drug reactions (>25%) in
IMLYGIC™-treated patients were fatigue, chills, pyrexia, nausea,
influenza-like illness, and injection site pain. Pyrexia, chills,
and influenza-like illness can occur at any time during IMLYGIC™
treatment, but were more frequent during the first 3 months of
treatment.
- The most common Grade 3 or higher adverse reaction was
cellulitis.
Please see full Prescribing Information and Medication Guide for
IMLYGIC™ at www.IMLYGIC.com.
About Vectibix® (panitumumab)
Vectibix is the first fully human monoclonal anti-epidermal growth
factor receptor (EGFR) antibody approved by the FDA for the
treatment of metastatic colorectal cancer (mCRC). Vectibix was
approved in the U.S. in September
2006 as a monotherapy for the treatment of patients with
EGFR-expressing mCRC after disease progression after prior
treatment with fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing chemotherapy.
In May 2014,
the FDA approved Vectibix for use in combination with
FOLFOX, as first-line treatment in patients with
wild-type KRAS (exon 2) mCRC. With this approval,
Vectibix became 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.
In Study 1, dermatologic toxicities occurred in 90% of patients
and were severe (NCI-CTC grade 3 and higher) in 15% of patients
with mCRC receiving Vectibix®. The clinical
manifestations included, but were not limited to, acneiform
dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia,
dry skin and skin fissures.
Monitor patients who develop dermatologic or soft tissue
toxicities while receiving Vectibix® for the
development of inflammatory or infectious sequelae.
Life-threatening and fatal infectious complications including
necrotizing fasciitis, abscesses and sepsis have been observed in
patients treated with Life-threatening and fatal bullous
mucocutaneous disease with blisters, erosions and skin sloughing
has also been observed in patients treated with
Vectibix®. It could not be determined whether
these mucocutaneous adverse reactions were directly related to EGFR
inhibition or to idiosyncratic immune-related effects (e.g.,
Stevens-Johnson syndrome or toxic epidermal necrolysis). Withhold
or discontinue Vectibix® for dermatologic or
soft tissue toxicity associated with severe or life-threatening
inflammatory or infectious complications. Dose modifications for
Vectibix concerning dermatologic toxicity are provided in the
product labeling. 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 either
KRAS 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. Other electrolyte disturbances,
including hypokalemia, have also been observed. Replete magnesium
and other electrolytes as appropriate.
In Study 1, 4% of patients experienced infusion reactions and 1%
of patients experienced severe infusion reactions (NCI-CTC grade
3-4). Infusion reactions, manifesting as fever, chills, dyspnea,
bronchospasm, and hypotension, can occur following
Vectibix® administration. Fatal infusion
reactions occurred in postmarketing experience. Terminate the
infusion for severe infusion reactions.
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.
In patients with a history of interstitial pneumonitis or
pulmonary fibrosis, or evidence of interstitial pneumonitis or
pulmonary fibrosis, the benefits of therapy with
Vectibix® versus the risk of pulmonary
complications must be carefully considered.
Exposure to sunlight can exacerbate dermatologic toxicity.
Advise patients to wear sunscreen and hats and limit sun exposure
while receiving Vectibix®.
Keratitis and ulcerative keratitis, known risk factors for
corneal perforation, have been reported with
Vectibix® use. Monitor for evidence of
keratitis or ulcerative keratitis. Interrupt or discontinue
Vectibix® for acute or worsening
keratitis.
In an interim analysis of an open-label, multicenter, randomized
clinical trial in the first-line setting in patients with mCRC, the
addition of Vectibix® to the combination of
bevacizumab and chemotherapy resulted in decreased OS and increased
incidence of NCI-CTC grade 3–5 (87% vs 72%) adverse reactions.
NCI-CTC grade 3–4 adverse reactions occurring at a higher rate in
Vectibix®-treated patients included
rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%),
dehydration (16% vs 5%; primarily occurring in patients with
diarrhea), hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs
< 1%), and hypomagnesemia (4% vs 0).
NCI-CTC grade 3–5 pulmonary embolism occurred at a higher rate
in Vectibix®-treated patients (7% vs 3%) and
included fatal events in three (< 1%)
Vectibix®-treated patients.
As a result of the toxicities experienced, patients randomized
to Vectibix®, bevacizumab and chemotherapy
received a lower mean relative dose intensity of each
chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or
infusional 5-FU) over the first 24 weeks on study, compared with
those randomized to bevacizumab and chemotherapy.
Advise patients of the need for adequate contraception in both
males and females while receiving
Vectibix® and for 6 months after the last
dose of Vectibix® therapy.
Vectibix® may be transmitted from the mother
to the developing fetus, and has the potential to cause fetal harm
when administered to pregnant women.
Because many drugs are excreted into human milk and because of
the potential for serious adverse reactions in nursing infants from
Vectibix®, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother. If nursing is
interrupted, it should not be resumed earlier than 2 months
following the last dose of Vectibix®.
Women who become pregnant during
Vectibix® treatment are encouraged to enroll
in Amgen's Pregnancy Surveillance Program. Women who are
nursing during Vectibix® treatment are
encouraged to enroll in Amgen's Lactation Surveillance
Program. Patients or their physicians should call
1-800-77-AMGEN (1-800-772-6436) to enroll.
In Study 1, the most common adverse reactions (> 20%)
with Vectibix® were skin rash with variable
presentations, paronychia, fatigue, nausea, and diarrhea. The most
common (> 5%) serious adverse reactions in the
Vectibix® arm were general physical health
deterioration and intestinal obstruction.
In Study 3, 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) 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 Vectibix® Prescribing Information,
including Boxed Warning visit www.vectibix.com.
In the EU, Vectibix is currently indicated for the treatment of
adult patients with wild-type RAS mCRC:
- in first-line in combination with FOLFOX and FOLFIRI.
- in second-line in combination with FOLFIRI for patients who
have received first-line fluoropyrimidine-based chemotherapy
(excluding irinotecan).
- as monotherapy after failure of fluoropyrimidine-,
oxaliplatin-, and irinotecan-containing chemotherapy regimens.
About Neulasta® (pegfilgrastim)
Neulasta is indicated to decrease the incidence of infection, as
manifested by febrile neutropenia, in patients with nonmyeloid
malignancies receiving myelosuppressive anti-cancer 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 was shown to significantly reduce the
incidence of febrile neutropenia..
Neulasta is administered by manual injection and is also
available via the Neulasta®
OnproTM kit, which was approved by
the FDA in 2014 and includes a specially designed,
single-use prefilled syringe co-packaged with an on-body injector
for Neulasta.
For more information about Neulasta,
visit www.Neulasta.com and www.NeulastaHCP.com.
Important Safety Information Regarding
Neulasta®
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.
Glomerulonephritis
Glomerulonephritis has been
reported in patients receiving Neulasta®. The diagnoses were based
upon azotemia, hematuria (microscopic and macroscopic),
proteinuria, and renal biopsy. Generally, events of
glomerulonephritis resolved after withdrawal of Neulasta®.
If glomerulonephritis is suspected, evaluate for cause. If
causality is likely, consider dose‐reduction or interruption of
Neulasta®.
Leukocytosis
White blood cell counts of 100 x 109/L
or greater have been observed in patients receiving pegfilgrastim.
Monitoring of CBCs during pegfilgrastim therapy is recommended.
Capillary Leak Syndrome
Capillary leak syndrome has
been reported after granulocyte colony‐stimulating factor (G‐CSF)
administration, including Neulasta®, and is
characterized by hypotension, hypoalbuminemia, edema, and
hemoconcentration. Episodes vary in frequency, severity and may be
life‐threatening if treatment is delayed. Patients who develop
symptoms of capillary leak syndrome should be closely monitored and
receive standard symptomatic treatment, which may include a need
for intensive care.
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.
About ABP 215
ABP 215 is being developed as a
biosimilar to bevacizumab, which is approved in specific
combinations in the U.S., EU and other regions for the treatment of
patients with unresectable, locally advanced, recurrent or
metastatic non-squamous NSCLC as well as metastatic carcinoma of
the colon or rectum; metastatic renal cell carcinoma; and other
region-specific indications.
About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc.
(then Watson Pharmaceuticals, Inc.) formed a collaboration to
develop and commercialize, on a worldwide basis, four oncology
antibody biosimilar medicines. This collaboration reflects the
shared belief that the development and commercialization of
biosimilar products will not follow a pure brand or generic model,
and will require significant expertise, infrastructure, and
investment to ensure safe, reliably supplied therapies for
patients. Under the terms of the agreement, Amgen will
assume primary responsibility for developing, manufacturing and
initially commercializing the oncology antibody products.
About Amgen Biosimilars
Amgen Biosimilars is
committed to building upon Amgen's experience in the
development and manufacturing of innovative human therapeutics to
expand Amgen's reach to patients suffering from serious
illnesses. Biosimilars offer the potential to increase patient
access to vital medicines, and Amgen is well positioned
to leverage its 35 years of experience in biotechnology to create
high-quality biosimilars and reliably supply them to patients
worldwide.
For more information,
visit www.amgenbiosimilars.com and follow us
www.twitter.com/amgenbiosim.
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 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 Amgen's Commitment to Oncology
Amgen Oncology
is committed to helping patients take on some of the toughest
cancers, such as those that have been resistant to drugs, those
that progress rapidly through the body and those where limited
treatment options exist. Amgen's supportive care treatments help
patients combat certain side effects of strong chemotherapy, and
our targeted medicines and immunotherapies focus on more than a
dozen different malignancies, ranging from blood cancers to solid
tumors. With decades of experience providing therapies for cancer
patients, Amgen continues to grow its portfolio of innovative and
biosimilar oncology medicines.
Forward Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen. 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 reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
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 the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
selected. We develop product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product
candidates that are derived from relationships may be subject to
disputes between the parties or may 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 results may be affected by our ability to successfully
market both new and existing products domestically and
internationally, clinical and regulatory developments involving
current and future products, sales growth of recently launched
products, competition from other products including biosimilars,
difficulties or delays in manufacturing our products and global
economic conditions. In addition, sales of our products are
affected by pricing pressure, political and public scrutiny and
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. Furthermore, our research, testing,
pricing, marketing and other operations are subject to extensive
regulation by domestic and foreign government regulatory
authorities. 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. In addition, our business
may be impacted by the adoption of new tax legislation or exposure
to additional tax liabilities. 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.
Further, while we routinely obtain patents for our products and
technology, the protection offered by our patents and patent
applications may be challenged, invalidated or circumvented by our
competitors, or we may fail to prevail in present and future
intellectual property litigation. We perform a substantial amount
of our commercial manufacturing activities at a few key facilities
and also depend on third parties for a portion of our manufacturing
activities, and limits on supply may constrain sales of certain of
our current products and product candidate development. In
addition, we compete with other companies with respect to many of
our marketed products as well as for the discovery and development
of new products. Further, some raw materials, medical devices and
component parts for our products are supplied by sole third-party
suppliers. 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 acquire other companies or products and to integrate
the operations of companies we have acquired may not be successful.
We may not be able to access the capital and credit markets on
terms that are favorable to us, or at all. We are increasingly
dependent on information technology systems, infrastructure and
data security. Our stock price is volatile and may be affected by a
number of events. 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 our 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, 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 U.S. Food and Drug
Administration 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.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(Media)
Kristen Neese, 805-313-8267
(Media)
Arvind Sood, 805-447-1060
(Investors)
References
- Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors
in Multiple Myeloma: 10 Years Later. Blood. 2012;
120(5):947-959.
- Kyprolis® [package insert]. Thousand Oaks, CA: Amgen; 2016.
- Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012;
121(6):893-897.
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SOURCE Amgen