Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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12g3-2(b): 82-_____________
26 July 2017 16:45 BST
FASLODEX
RECEIVES EU APPROVAL AS
FIRST-
LINE THERAPY FOR ADVANCED BREAST CANCER
Faslodex reduced risk of disease progression by 20%
vs anastrozole, the current standard treatment option
Potential new first-line standard of care for postmenopausal women
with
oestrogen-receptor positive locally-advanced or metastatic
disease
AstraZeneca
today announced that the European Commission (EC) has approved
Faslodex (fulvestrant) for
the treatment of oestrogen-receptor positive, locally-advanced or
metastatic breast cancer in postmenopausal women not previously
treated with endocrine therapy.
The EU
approval is based on pivotal data from the Phase III FALCON trial,
which demonstrated the superiority of Faslodex 500mg over anastrozole 1mg as
a first-line treatment for postmenopausal women with
locally-advanced or HR+ metastatic breast cancer who had not
received prior hormone-based therapy.
In the
FALCON trial, median progression-free survival (PFS) was
significantly longer with Faslodex than with the aromatase
inhibitor, anastrozole - 16.6 months versus 13.8 months (HR: 0.797;
95% CI: 0.637-0.999; p=0.0486). Aromatase inhibitors such as
anastrozole are the current standard of care for the first-line
treatment for postmenopausal women with HR+ advanced breast
cancer.
Jamie Freedman, Executive Vice-President and Head of AstraZeneca's
Oncology Business Unit, said: "This new EU approval shows the
scientific strength of Faslodex with more than 15 years of clinical experience.
Postmenopausal women with hormone receptor-positive advanced breast
cancer can now benefit from Faslodex at an earlier stage in their disease. We continue
to explore the full potential of this important medicine as
monotherapy and in combination with other
medicines."
Matthew Ellis, MD, PhD, study investigator, and director of the
Lester and Sue Smith Breast Center in the Dan L Duncan
Comprehensive Cancer Center at Baylor College of Medicine in
Houston, said: "A 20% reduction in disease progression or death
observed with fulvestrant compared to the current standard therapy
is an advance in the management of postmenopausal women diagnosed
with previously untreated hormone receptor-positive advanced breast
cancer. The study provides evidence that the earlier use of
fulvestrant in these patients will prolong the time before the
disease progresses, which requires a change to a second line
drug."
The safety and tolerability profiles for Faslodex and anastrozole reported in the FALCON trial
were in line with current experience. The most-commonly reported
adverse events (AEs) in the Faslodex and anastrozole arms were arthralgia (16.7%
vs. 10.3%), hot flush (11.4% vs. 10.3%) and nausea (10.5% vs.
10.3%).
Faslodex is the only
hormonal medicine for advanced breast cancer that slows tumour
growth by binding to and degrading the oestrogen receptor - a key
driver of breast cancer progression in some women. It is widely
approved for the treatment of HR+ advanced breast cancer in
postmenopausal women with disease progression following
anti-oestrogen medicine.
Faslodex was first
approved in 2002 and is currently being tested in combination with
over 19 different medicines for the treatment of women with
advanced HR+ breast cancer.
About FALCON
The
FALCON (Fulvestrant and AnastrozoLe COmpared in hormonal
therapy-Naïve advanced breast cancer) trial is a Phase III,
randomised, double-blind, multicentre trial comparing the
antitumour effects and tolerability profile of a 500mg dose of
Faslodex plus placebo with
a 1mg dose of anastrozole plus placebo, in postmenopausal women
with HR+, locally-advanced or metastatic breast cancer who have not
been treated previously with any hormonal medicine.
The
FALCON trial was designed on the basis of positive results from the
Phase II FIRST trial, which demonstrated a median overall survival
nearly six months longer with Faslodex compared to
anastrozole.
About Advanced Breast Cancer
Advanced/metastatic
breast cancer refers to Stage III and IV breast cancer. Stage III
disease may also be referred to as locally-advanced breast cancer,
while metastatic disease is the most-advanced stage of breast
cancer (Stage IV), and occurs when cancer cells have spread beyond
the initial tumour site to other organs of the body outside the
breast. Since there is no cure for the disease, the goal of current
treatment is to delay disease worsening or death.
About Faslodex
Faslodex (fulvestrant) is indicated for the treatment of
oestrogen receptor positive, locally advanced or metastatic breast
cancer in postmenopausal women not previously treated with
endocrine therapy, or with disease relapse on or after adjuvant
anti-oestrogen therapy, or disease progression on anti-oestrogen
therapy.
In the
US, Faslodex is also
approved, in combination with palbociclib, for the treatment of
women with HR+, HER2-negative advanced or metastatic breast cancer,
whose cancer has progressed after endocrine medicine. Faslodex represents a hormonal
treatment approach that helps to slow tumour growth by blocking and
degrading the oestrogen receptor - a key driver of disease
progression.
About AstraZeneca in Oncology
AstraZeneca
has a deep-rooted heritage in Oncology and offers a quickly-growing
portfolio of new medicines that has the potential to transform
patients' lives and the Company's future. With at least six new
medicines to be launched between 2014 and 2020, and a broad
pipeline of small molecules and biologics in development, we are
committed to advance New Oncology as one of AstraZeneca's five
Growth Platforms focused on lung, ovarian, breast and blood
cancers. In addition to our core capabilities, we actively pursue
innovative partnerships and investments that accelerate the
delivery of our strategy as illustrated by our investment in Acerta
Pharma in haematology.
By
harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody-Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment 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 commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please
visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
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Date:
26 July 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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