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 June 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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12g3-2(b): 82-_____________
23 June 2017 12:45 BST
FASLODEX (FULVESTRANT)
RECEIVES POSITIVE CHMP OPINION FOR USE IN 1st-LINE HORMONE
RECEPTOR-POSITIVE ADVANCED BREAST CANCER
CHMP positive recommendation is based on Phase III data
demonstrating
a 20% reduction in risk of disease worsening or death over
anastrozole
AstraZeneca
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion, recommending the marketing authorisation of
Faslodex (fulvestrant) for
the treatment of hormone receptor-positive (HR+), 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.
The
CHMP recommendation is based on pivotal data from the Phase III
FALCON trial, where Faslodex 500mg demonstrated superiority
over anastrozole 1mg in the treatment of locally-advanced or
metastatic breast cancer in post-menopausal women who had not
received prior hormonal-based medicine for HR+ breast
cancer.
The
FALCON data show that the delay in disease worsening or death
(median progression-free survival, PFS) was 2.8 months longer with
Faslodex than anastrozole.
The median PFS was 16.6 months in the Faslodex arm compared with 13.8 months
in the anastrozole arm. Aromatase inhibitors such as anastrozole
are the current standard of care for the 1st-line treatment for
postmenopausal women with HR+ advanced breast cancer.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "Faslodex has long been an effective
medicine for women with advanced breast cancer in later lines of
treatment and we are pleased that the CHMP has recognised its
potential as a first-line option. Faslodex is also being tested in
combination with over 19 different medicines, which is testament to
its well-established safety and efficacy profile with over 15 years
of patient evidence since its first launch in 2002."
The
safety and tolerability profile was in line with current experience
with Faslodex and
anastrozole. 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 hormone 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.
The
CHMP's positive opinion will now be reviewed by the European
Commission, which has the authority to approve medicines for the
European Union (EU). The final decision will be applicable to all
28 EU member countries plus Iceland, Norway and
Liechtenstein.
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
postmenopausal women with oestrogen receptor-positive (ER+),
locally-advanced or metastatic breast cancer with disease relapse
on or after adjuvant anti-oestrogen treatment, or disease
progression on treatment with an antioestrogen.
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
Date:
23 June 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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