TIDMAZN
RNS Number : 4790Z
AstraZeneca PLC
27 May 2016
ASTRAZENECA'S FASLODEX MET PRIMARY ENDPOINT IN FIRST-LINE
TREATMENT OF ADVANCED BREAST CANCER
AstraZeneca today announced positive results from the Phase III
FALCON trial comparing Faslodex 500mg (fulvestrant) to Arimidex 1mg
(anastrozole) for the treatment of locally-advanced or metastatic
breast cancer, in post-menopausal women who have not had prior
hormonal treatment for hormone-receptor-positive (HR+) breast
cancer.
Faslodex 500mg demonstrated superiority compared with Arimidex
1mg in FALCON, and met its primary endpoint of extended
progression-free survival. The trial showed an adverse event
profile generally consistent with current knowledge of the safety
profile of the medicines.
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: "The
FALCON results bring us closer to offering more and earlier
treatment options to postmenopausal women with HR+ locally-advanced
or metastatic breast cancer; the potential to delay disease
progression is important for these patients as there is currently
no cure. Faslodex has over 10 years of clinical evidence and we are
committed to exploring its potential along with the rest of our
outstanding oncology portfolio."
A full evaluation of the data is ongoing and the results are
expected to be presented at a medical meeting in 2016.
Aromatase inhibitors (such as Arimidex) are the current standard
of care in first-line treatment for postmenopausal women with
advanced HR+ breast cancer.(i)
Faslodex 500mg is approved for the treatment of postmenopausal
women with oestrogen-receptor (ER)-positive locally-advanced or
metastatic breast cancer whose cancer has progressed following
anti-oestrogen therapy.(ii) Most recently, on 2 March 2016, the US
Food and Drug Administration approved Faslodex 500mg, in
combination with palbociclib, for the treatment of women with
hormone-receptor-positive, human-epidermal-growth-factor-receptor
2-negative (HER2-) advanced or metastatic breast cancer (MBC),
whose cancer has progressed after endocrine therapy.(iii)
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. The trial compared the
anti-tumour effects and tolerability profile of a 500mg dose of
Faslodex plus placebo with a 1mg dose of Arimidex plus placebo, in
postmenopausal women with hormone-receptor-positive,
locally-advanced or metastatic breast cancer who have not been
treated previously with any hormonal therapy.
About Advanced breast cancer (ABC)
ABC is the most advanced stage of breast cancer (stage IV), and
occurs when cancer cells have spread beyond the initial tumour site
to other parts of the body outside of the breast. Since there is no
cure for ABC, the goal of current treatment is to delay disease
progression.(iv)
About Faslodex 500mg (fulvestrant)
Faslodex 500mg is indicated for the treatment of postmenopausal
women with ER+, locally-advanced or metastatic breast cancer for
disease relapse on or after adjuvant anti-oestrogen therapy, or
disease progression on therapy with an anti-oestrogen.(2)
In the US, Faslodex 500mg is also approved, in combination with
palbociclib, for the treatment of US women with HR+, human
epidermal growth factor receptor 2-negative (HER2-) advanced or
metastatic breast cancer (MBC), whose cancer has progressed after
endocrine therapy. Faslodex 500mg represents a hormonal therapy
approach that helps to slow tumour growth by blocking and degrading
the oestrogen receptor - a key driver of disease
progression.(v)
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 6 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 six
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, the genetic drivers of cancer 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, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialisation of prescription medicines, primarily for the
treatment of diseases in three main therapy areas - respiratory,
inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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
References
i Journal of Clinical Oncology. Endocrine Therapy for Hormone
Receptor-Positive Metastatic Breast Cancer: American Society of
Clinical Oncology Guideline. Available at:
http://jco.ascopubs.org/content/early/2016/05/19/JCO.2016.67.1487.full.pdf+html.
Last accessed 25.05.2016
ii FASLODEX Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human
/000540/WC500021174.pdf. Last accessed 25/02/2016
iiiFASLODEX full Prescribing Information. AstraZeneca
Pharmaceuticals LP, Wilmington, DE
ivNational Cancer Institute. What Is Cancer?: Metastatic Cancer.
Available online at:
http://www.cancer.gov/about-cancer/what-is-cancer/metastatic-fact-sheet.
Last accessed 25/04/2016.
vHowell A. Is fulvestrant ("Faslodex") just another selective
estrogen receptor modulator? Int J
Gynecol Cancer. 2006;16 (suppl 2):521-523.
CONTACTS
Media Enquiries
Neil Burrows UK/Global +44 7842 350541
Vanessa Rhodes UK/Global +44 7880 400690
Karen Birmingham UK/Global +44 7818 524012
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 7818 524185
Nick Stone RIA, CVMD +44 7717 618834
Henry Wheeler Oncology +44 7788 354619
Craig Marks Finance +44 7881 615764
Christer Gruvris ING, Consensus Forecasts +44 7827 836825
US
Lindsey Trickett CVMD, Oncology +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience
and Gastrointestinal
27 May 2016
-ENDS-
This information is provided by RNS
The company news service from the London Stock Exchange
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