Based on ground-breaking DESTINY-Breast03
results showing AstraZeneca and Daiichi Sankyo’s ENHERTU reduced
the risk of disease progression or death by 72% versus trastuzumab
emtansine (T-DM1)
Application being evaluated under FDA
Real-Time Oncology Review and Project Orbis
Please replace the release with the following corrected version
due to multiple revisions.
The updated release reads:
ENHERTU® GRANTED PRIORITY REVIEW IN THE US
FOR PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER TREATED
WITH A PRIOR ANTI-HER2-BASED REGIMEN
Based on ground-breaking DESTINY-Breast03
results showing AstraZeneca and Daiichi Sankyo’s ENHERTU reduced
the risk of disease progression or death by 72% versus trastuzumab
emtansine (T-DM1)
Application being evaluated under FDA
Real-Time Oncology Review and Project Orbis
AstraZeneca and Daiichi Sankyo have received notification of
acceptance of the supplemental Biologics License Application (sBLA)
of ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of
adult patients in the US with unresectable or metastatic
HER2-positive breast cancer who have received a prior
anti-HER2-based regimen. The application has also been granted
Priority Review.
ENHERTU is a HER2-directed antibody drug conjugate (ADC) being
jointly developed by AstraZeneca and Daiichi Sankyo.
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that, if approved, would offer
significant improvements over available options by demonstrating
safety or efficacy improvements, preventing serious conditions, or
enhancing patient compliance.1 The Prescription Drug User Fee Act
(PDUFA) date, the FDA action date for their regulatory decision, is
during the second quarter of 2022.
The sBLA is being reviewed under the Real-Time Oncology Review
(RTOR) program and Project Orbis, two initiatives of the FDA which
are designed to bring effective cancer treatments to patients as
early as possible. RTOR allows the FDA to review components of an
application before submission of the complete application. Project
Orbis provides a framework for concurrent submission and review of
oncology medicines among participating international partners.
Breast cancer is the most common cancer worldwide, with more
than two million cases diagnosed in 2020, resulting in nearly
685,000 deaths globally.2 Approximately one in five cases of breast
cancer are considered HER2-positive.3 Despite initial treatment
with trastuzumab and a taxane, patients with HER2-positive
metastatic breast cancer will often experience disease
progression.4 More treatment options are needed to further delay
progression and extend survival.4-6
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca said: “This review across geographies and the Priority
Review in the US as part of Project Orbis is so important because
it speaks to the transformative potential of ENHERTU based on the
unprecedented progression-free survival benefit in this setting.
The news reinforces the importance of bringing this potential new
option to patients as quickly as possible.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “This
regulatory review of ENHERTU in the US marks the first time this
medicine is participating in both the Real-Time Oncology Review and
Project Orbis programs. The FDA’s prioritization of our application
underscores the potential of this medicine and the continued need
to expedite the availability of new treatment options, while making
it possible to potentially receive approvals in several countries
concurrently.”
The sBLA is based on data from the DESTINY-Breast03 trial
presented during the European Society for Medical Oncology (ESMO)
Congress 2021.
In the trial, ENHERTU demonstrated a 72% reduction in the risk
of disease progression or death compared to T-DM1 (hazard ratio
[HR] 0.28; 95% confidence interval [CI]: 0.22-0.37; p=7.8x10-22) in
patients with HER2-positive unresectable and/or metastatic breast
cancer previously treated with trastuzumab and a taxane.
DESTINY-Breast03 also recorded that nearly all patients treated
with ENHERTU during the trial were alive at one year (94.1%)
compared to 85.9% of patients treated with T-DM1. Confirmed
objective response rate (ORR) more than doubled in the ENHERTU arm
versus the T-DM1 arm (79.7% vs. 34.2%). The safety profile of
ENHERTU was consistent with previous clinical trials, with no new
safety concerns identified and no Grade 4 or 5 treatment-related
interstitial lung disease events.
In September 2021, ENHERTU received its fourth Breakthrough
Therapy Designation (BTD) in the US for the treatment of adult
patients with unresectable or metastatic HER2-positive breast
cancer who have received one or more prior anti-HER2-based
regimens.
ENHERTU is approved for the treatment of adult patients with
unresectable or metastatic HER2-positive breast cancer who have
received two or more prior anti-HER2-based regimens in more than 30
countries based on the results from the DESTINY-Breast01 trial.
ENHERTU is being further assessed in a comprehensive clinical
development program evaluating efficacy and safety across multiple
HER2-targetable cancers, including breast, gastric, lung and
colorectal cancers.
Important Safety Information
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor
conjugate indicated for the treatment of adult patients with:
- Unresectable or metastatic HER2-positive breast cancer who have
received two or more prior anti-HER2-based regimens in the
metastatic setting. This indication is approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial.
- Locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction adenocarcinoma who have received a prior
trastuzumab-based regimen.
WARNING: INTERSTITIAL LUNG DISEASE and
EMBRYO-FETAL TOXICITY
- Interstitial lung disease (ILD) and pneumonitis, including
fatal cases, have been reported with ENHERTU. Monitor for and
promptly investigate signs and symptoms including cough, dyspnea,
fever, and other new or worsening respiratory symptoms. Permanently
discontinue ENHERTU in all patients with Grade 2 or higher
ILD/pneumonitis. Advise patients of the risk and to immediately
report symptoms.
- Exposure to ENHERTU during pregnancy can cause embryo-fetal
harm. Advise patients of these risks and the need for effective
contraception.
Contraindications
None.
Warnings and Precautions
Severe, life-threatening, or fatal interstitial lung disease
(ILD), including pneumonitis, can occur in patients treated with
ENHERTU. Advise patients to immediately report cough, dyspnea,
fever, and/or any new or worsening respiratory symptoms. Monitor
patients for signs and symptoms of ILD. Promptly investigate
evidence of ILD. Evaluate patients with suspected ILD by
radiographic imaging. Consider consultation with a pulmonologist.
For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until
resolved to Grade 0, then if resolved in ≤28 days from date of
onset, maintain dose. If resolved in >28 days from date of
onset, reduce dose one level. Consider corticosteroid treatment as
soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day
prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade
2 or greater), permanently discontinue ENHERTU. Promptly initiate
systemic corticosteroid treatment as soon as ILD/pneumonitis is
suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and
continue for at least 14 days followed by gradual taper for at
least 4 weeks.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer treated with ENHERTU 5.4
mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD
and/or pneumonitis occurred in 2.6% of patients treated with
ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to
8.3).
Locally Advanced or Metastatic Gastric
Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median
time to first onset was 2.8 months (range: 1.2 to 21.0).
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in
patients treated with ENHERTU. Monitor complete blood counts prior
to initiation of ENHERTU and prior to each dose, and as clinically
indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC]
<1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2
or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x
109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce
dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and
temperature >38.3ºC or a sustained temperature of ≥38ºC for more
than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one
level.
Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or
metastatic HER2-positive breast cancer who received ENHERTU
5.4mg/kg, a decrease in neutrophil count was reported in 62% of
patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil
count. Median time to first onset of decreased neutrophil count was
23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7%
of patients.
Locally Advanced or Metastatic Gastric
Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported
in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased
neutrophil count. Median time to first onset of decreased
neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia
was reported in 4.8% of patients.
Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of
developing left ventricular dysfunction. Left ventricular ejection
fraction (LVEF) decrease has been observed with anti-HER2
therapies, including ENHERTU. In the 234 patients with unresectable
or metastatic HER2-positive breast cancer who received ENHERTU, two
cases (0.9%) of asymptomatic LVEF decrease were reported. In
DESTINY-Gastric01, of the 125 patients with locally advanced or
metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with
ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were
reported; however, on echocardiography, 8% were found to have
asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has
not been studied in patients with a history of clinically
significant cardiac disease or LVEF <50% prior to initiation of
treatment.
Assess LVEF prior to initiation of ENHERTU and at regular
intervals during treatment as clinically indicated. When LVEF is
>45% and absolute decrease from baseline is 10-20%, continue
treatment with ENHERTU. When LVEF is 40-45% and absolute decrease
from baseline is <10%, continue treatment with ENHERTU and
repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and
absolute decrease from baseline is 10-20%, interrupt ENHERTU and
repeat LVEF assessment within 3 weeks. If LVEF has not recovered to
within 10% from baseline, permanently discontinue ENHERTU. If LVEF
recovers to within 10% from baseline, resume treatment with ENHERTU
at the same dose. When LVEF is <40% or absolute decrease from
baseline is >20%, interrupt ENHERTU and repeat LVEF assessment
within 3 weeks. If LVEF of <40% or absolute decrease from
baseline of >20% is confirmed, permanently discontinue ENHERTU.
Permanently discontinue ENHERTU in patients with symptomatic
congestive heart failure.
Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant
woman. Advise patients of the potential risks to a fetus. Verify
the pregnancy status of females of reproductive potential prior to
the initiation of ENHERTU. Advise females of reproductive potential
to use effective contraception during treatment and for at least 7
months following the last dose of ENHERTU. Advise male patients
with female partners of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 4
months after the last dose of ENHERTU.
Additional Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L)
interrupt ENHERTU until resolved to Grade 1 or less, then maintain
dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L)
interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by
one level.
Adverse Reactions
Metastatic Breast Cancer
The safety of ENHERTU was evaluated in a pooled analysis of 234
patients with unresectable or metastatic HER2-positive breast
cancer who received at least one dose of ENHERTU 5.4 mg/kg in
DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered
by intravenous infusion once every three weeks. The median duration
of treatment was 7 months (range: 0.7 to 31).
Serious adverse reactions occurred in 20% of patients receiving
ENHERTU. Serious adverse reactions in >1% of patients who
received ENHERTU were interstitial lung disease, pneumonia,
vomiting, nausea, cellulitis, hypokalemia, and intestinal
obstruction. Fatalities due to adverse reactions occurred in 4.3%
of patients including interstitial lung disease (2.6%), and the
following events occurred in one patient each (0.4%): acute hepatic
failure/acute kidney injury, general physical health deterioration,
pneumonia, and hemorrhagic shock.
ENHERTU was permanently discontinued in 9% of patients, of which
ILD accounted for 6%. Dose interruptions due to adverse reactions
occurred in 33% of patients treated with ENHERTU. The most frequent
adverse reactions (>2%) associated with dose interruption were
neutropenia, anemia, thrombocytopenia, leukopenia, upper
respiratory tract infection, fatigue, nausea, and ILD. Dose
reductions occurred in 18% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were fatigue, nausea, and neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were nausea (79%), white blood cell count decreased
(70%), hemoglobin decreased (70%), neutrophil count decreased
(62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate
aminotransferase increased (41%), alanine aminotransferase
increased (38%), platelet count decreased (37%), constipation
(35%), decreased appetite (32%), anemia (31%), diarrhea (29%),
hypokalemia (26%), and cough (20%).
Locally Advanced or Metastatic Gastric
Cancer
The safety of ENHERTU was evaluated in 187 patients with locally
advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma
in DESTINY‑Gastric01. Patients intravenously received at least one
dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or
either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80
mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6
months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months
(range: 0.5 to 13.1) in the irinotecan/paclitaxel group.
Serious adverse reactions occurred in 44% of patients receiving
ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients
who received ENHERTU were decreased appetite, ILD, anemia,
dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor
hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of
patients: disseminated intravascular coagulation, large intestine
perforation, and pneumonia occurred in one patient each (0.8%).
ENHERTU was permanently discontinued in 15% of patients, of
which ILD accounted for 6%. Dose interruptions due to adverse
reactions occurred in 62% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
interruption were neutropenia, anemia, decreased appetite,
leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia,
upper respiratory tract infection, diarrhea, and hypokalemia. Dose
reductions occurred in 32% of patients treated with ENHERTU. The
most frequent adverse reactions (>2%) associated with dose
reduction were neutropenia, decreased appetite, fatigue, nausea,
and febrile neutropenia.
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were hemoglobin decreased (75%), white blood cell
count decreased (74%), neutrophil count decreased (72%), lymphocyte
count decreased (70%), platelet count decreased (68%), nausea
(63%), decreased appetite (60%), anemia (58%), aspartate
aminotransferase increased (58%), fatigue (55%), blood alkaline
phosphatase increased (54%), alanine aminotransferase increased
(47%), diarrhea (32%), hypokalemia (30%), vomiting (26%),
constipation (24%), blood bilirubin increased (24%), pyrexia (24%),
and alopecia (22%).
Use in Specific Populations
- Pregnancy: ENHERTU can cause fetal harm when
administered to a pregnant woman. Advise patients of the potential
risks to a fetus. There are clinical considerations if ENHERTU is
used in pregnant women, or if a patient becomes pregnant within 7
months following the last dose of ENHERTU.
- Lactation: There are no data regarding the presence of
ENHERTU in human milk, the effects on the breastfed child, or the
effects on milk production. Because of the potential for serious
adverse reactions in a breastfed child, advise women not to
breastfeed during treatment with ENHERTU and for 7 months after the
last dose.
- Females and Males of Reproductive Potential:
Pregnancy testing: Verify pregnancy
status of females of reproductive potential prior to initiation of
ENHERTU. Contraception: Females:
ENHERTU can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 7
months following the last dose. Males: Advise male patients with
female partners of reproductive potential to use effective
contraception during treatment with ENHERTU and for at least 4
months following the last dose. Infertility: ENHERTU may impair male reproductive
function and fertility.
- Pediatric Use: Safety and effectiveness of ENHERTU have
not been established in pediatric patients.
- Geriatric Use: Of the 234 patients with HER2-positive
breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years
and 5% were ≥75 years. No overall differences in efficacy were
observed between patients ≥65 years of age compared to younger
patients. There was a higher incidence of Grade 3-4 adverse
reactions observed in patients aged ≥65 years (53%) as compared to
younger patients (42%). Of the 125 patients with locally advanced
or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated
with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and
14% were ≥75 years. No overall differences in efficacy or safety
were observed between patients ≥65 years of age compared to younger
patients.
- Hepatic Impairment: In patients with moderate hepatic
impairment, due to potentially increased exposure, closely monitor
for increased toxicities related to the topoisomerase
inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi
Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or
fda.gov/medwatch.
Please see accompanying full Prescribing Information,
including Boxed WARNINGS, and Medication Guide.
HER2-positive breast cancer
Breast cancer is the most common cancer and is one of the
leading causes of cancer-related deaths in women worldwide.2 More
than two million patients with breast cancer were diagnosed in
2020, resulting in nearly 685,000 deaths globally.2 Approximately
one in five cases of breast cancer are considered
HER2-positive.3
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumors, including breast,
gastric, lung and colorectal cancers.7 HER2 protein overexpression
may occur as a result of HER2 gene amplification and is often
associated with aggressive disease and poor prognosis in breast
cancer.8
Despite initial treatment with trastuzumab and a taxane, people
with HER2-positive metastatic breast cancer will often experience
disease progression.4 More treatment options are needed to further
delay progression and extend survival.4-6
DESTINY-Breast03
DESTINY-Breast03 is a global head-to-head, randomized,
open-label, registrational Phase III trial evaluating the safety
and efficacy of ENHERTU (5.4mg/kg) versus T-DM1 in patients with
HER2-positive unresectable and/or metastatic breast cancer
previously treated with trastuzumab and a taxane.
The primary efficacy endpoint of DESTINY-Breast03 is
progression-free survival (PFS) based on blinded independent
central review. Secondary efficacy endpoints include overall
survival, objective response rate, duration of response, PFS based
on investigator assessment and safety.
DESTINY-Breast03 enrolled approximately 500 patients at multiple
sites in Asia, Europe, North America, Oceania and South America.
For more information about the trial, visit ClinicalTrials.gov.
ENHERTU
ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed
ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC
technology, ENHERTU is the lead ADC in the oncology portfolio of
Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC
scientific platform. ENHERTU consists of a HER2 monoclonal antibody
attached to a topoisomerase I inhibitor payload, an exatecan
derivative, via a stable tetrapeptide-based cleavable linker.
ENHERTU (5.4mg/kg) is approved in more than 30 countries for the
treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens based on the results from the
DESTINY-Breast01 trial. A Type II Variation is currently under
review by the European Medicines Agency (EMA) for the treatment of
adult patients with unresectable or metastatic HER2 positive breast
cancer who have received one or more prior anti-HER2-based regimens
based on the results from the DESTINY-Breast03 trial.
ENHERTU (6.4mg/kg) is approved in several countries for the
treatment of adult patients with locally advanced or metastatic
HER2-positive gastric or gastroesophageal junction adenocarcinoma
who have received a prior trastuzumab-based regimen based on the
results from the DESTINY-Gastric01 trial. A Type II Variation is
currently under review by the EMA for the treatment of adult
patients with locally advanced or metastatic HER2-positive gastric
or gastroesophageal junction adenocarcinoma who have received a
prior anti-HER2-based regimen.
ENHERTU development program
A comprehensive development program is underway globally,
evaluating the efficacy and safety of ENHERTU monotherapy across
multiple HER2-targetable cancers, including breast, gastric, lung
and colorectal cancers. Trials in combination with other anticancer
treatments, such as immunotherapy, are also underway.
ENHERTU was highlighted in the Clinical Cancer Advances 2021
report as one of two significant advancements in the “ASCO Clinical
Advance of the Year: Molecular Profiling Driving Progress in GI
Cancers,” based on data from both the DESTINY-CRC01 and
DESTINY-Gastric01 trials, as well as one of the targeted therapy
advances of the year in non-small cell lung cancer (NSCLC), based
on the interim results of the HER2-mutated cohort of the
DESTINY-Lung01 trial.
Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo)
and AstraZeneca entered into a global collaboration to jointly
develop and commercialize ENHERTU (a HER2-directed ADC) in March
2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in
July 2020, except in Japan where Daiichi Sankyo maintains exclusive
rights. Daiichi Sankyo is responsible for manufacturing and supply
of ENHERTU and datopotamab deruxtecan.
AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology,
AstraZeneca is starting to challenge, and redefine, the current
clinical paradigm for how breast cancer is classified and treated
to deliver even more effective treatments to patients in need –
with the bold ambition to one day eliminate breast cancer as a
cause of death.
AstraZeneca has a comprehensive portfolio of approved and
promising compounds in development that leverage different
mechanisms of action to address the biologically diverse breast
cancer tumor environment.
AstraZeneca aims to continue to transform outcomes for
HR-positive breast cancer with foundational medicines FASLODEX and
ZOLADEX and investigational agents next-generation oral SERD and
camizestrant.
PARP inhibitor LYNPARZA is a targeted treatment option for
metastatic breast cancer patients with an inherited BRCA mutation.
AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada)
continue to research LYNPARZA in metastatic breast cancer patients
with an inherited BRCA mutation and are exploring new opportunities
to treat these patients earlier in their disease.
Building on the first approval of ENHERTU, a HER2-directed ADC,
in previously treated HER2-positive metastatic breast cancer,
AstraZeneca and Daiichi Sankyo are exploring its potential in
earlier lines of treatment and in new breast cancer settings.
To bring much needed treatment options to patients with
triple-negative breast cancer, an aggressive form of breast cancer,
AstraZeneca is testing immunotherapy IMFINZI in combination with
other oncology medicines, including LYNPARZA and ENHERTU,
evaluating the potential of AKT kinase inhibitor, capivasertib, in
combination with chemotherapy, and collaborating with Daiichi
Sankyo to explore the potential of TROP2-directed ADC, datopotamab
deruxtecan.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
References
1. FDA. Priority Review. Available at:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
Accessed January 2022. 2. Sung H, et al. Global Cancer Statistics
2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for
36 Cancers in 185 Countries. CA Cancer J Clin. 2021;
10.3322/caac.21660. 3. Ahn S, et al. HER2 status in breast cancer:
changes in guidelines and complicating factors for interpretation.
J Pathol Transl Med. 2020; 54(1): 34-44. 4. Barok M, et al.
Trastuzumab emtansine: mechanism of action and drug resistance.
Breast Cancer Res. 2014; 16(2):209. 5. Mounsey L, et al. Changing
Natural History of HER2-Positive Breast Cancer Metastatic to the
Brain in the Era of New Targeted Therapies. Clin Breast Cancer.
2018; 18(1):29-37. 6. Martínez-Sáez O, et al. Current and Future
Management of HER2-Positive Metastatic Breast Cancer. JCO Oncol
Pract. 2021. 10.1200/OP.21.00172. 7. Iqbal N, et al. Human
Epidermal Growth Factor Receptor 2 (HER2) in Cancers:
Overexpression and Therapeutic Implications. Mol Biol Int.
2014;852748. 8. Pillai R, et al. HER2 mutations in lung
adenocarcinomas: A report from the Lung Cancer Mutation Consortium.
Cancer. 2017;1;123(21):4099-4105.
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Media Inquiries Brendan McEvoy +1 302 885 2677 Jessica
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