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 October
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
18
October 2017 07:00 BST
US FDA ACCEPTS REGULATORY SUBMISSION FOR
LYNPARZA IN METASTATIC BREAST CANCER AND
GRANTS PRIORITY REVIEW
Lynparza has the potential to offer a new treatment option for
patients with germline BRCA-mutated, HER2-negative metastatic
breast cancer
Regulatory submission acceptance is first for a PARP inhibitor
beyond ovarian cancer
AstraZeneca and Merck & Co., Inc., (Merck: known as MSD
outside the US and Canada) today
announced that the US Food and Drug Administration (FDA) has
accepted and granted priority review for a supplemental New Drug
Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with
germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have
been previously treated with chemotherapy in the neoadjuvant,
adjuvant, or metastatic settings. A Prescription Drug User
Fee Act date is set for the first quarter of 2018.
This is the first submission for a poly ADP-ribose
polymerase (PARP) inhibitor outside
ovarian cancer and the third indication submission for
Lynparza
in the US. The sNDA is based on the
positive results from the Phase III OlympiAD
trial published in the
New
England Journal of Medicine.
Lynparza was first approved in
December 2014 as a capsule formulation, making it the first ever
PARP inhibitor to be approved. Since then, Lynparza has been used to treat more than 3,000 advanced
ovarian cancer patients. Lynparza tablets are currently being tested in a range of
tumour types including breast, prostate and pancreatic
cancers.
About OlympiAD
OlympiAD is a randomised, open-label, multicenter Phase III trial
assessing the efficacy and safety of LYNPARZA tablets (300mg twice
daily) compared to 'physician's choice' chemotherapy (capecitabine,
vinorelbine, eribulin) in 302 patients with HER2-negative
metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to
be deleterious. The international trial was conducted in 19
countries across Europe, Asia, North America and South
America.
About Lynparza
(olaparib)
Lynparza was the first FDA-approved oral poly ADP-ribose
polymerase (PARP) inhibitor that may exploit tumour DNA damage
response (DDR) pathway deficiencies to potentially kill cancer
cells. Specifically, in
vitro studies have shown that olaparib-induced cytotoxicity
may involve inhibition of PARP enzymatic activity and increased
formation of PARP-DNA complexes, resulting in DNA damage and cancer
cell death.
Lynparza is the foundation of AstraZeneca's industry-leading
portfolio of potential new medicines targeting DDR mechanisms in
cancer cells.
About Metastatic Breast Cancer
Approximately
one in eight women will be diagnosed with breast cancer in the US,
based on 2012 - 2014 data.[[i]] In
2017 this would amount to more than 250,000 women who will be
diagnosed with breast cancer.[i] Despite treatment options increasing
during the past three decades, there is currently no cure for
patients diagnosed with metastatic breast cancer and the 5-year
relative survival rate for this patient population is currently
26.9%.[i,[ii],[iii]]
Thus, the primary aim of treatment is to slow progression of the
disease for as long as possible, improving, or at least
maintaining, a patient's quality of life.[ii]
About Germline BRCA mutations
BRCA1
and BRCA2 are human genes that produce proteins responsible for
repairing damaged DNA and play an important role in maintaining the
genetic stability of cells. When either of these genes is mutated,
or altered, such that its protein is either not made or is faulty,
DNA damage may not be repaired properly. As a result, cells are
more likely to develop additional genetic alterations that can lead
to cancer.[[iv]]
About the AstraZeneca and Merck Strategic Oncology
Collaboration
On 27 July 2017, AstraZeneca and Merck & Co., Inc., announced a
global strategic oncology collaboration to jointly develop and
commercialise AstraZeneca's Lynparza, the world's first and leading PARP inhibitor,
and potential new medicine selumetinib, a MEK inhibitor, for
multiple cancer types. The collaboration is based on increasing
evidence that PARP and MEK inhibitors can be combined with
PDL-1/PD-1 inhibitors for a range of tumour types and is aimed at
maximising the potential of Lynparza to
become the preferred backbone of combination therapies. Working
together, the companies will develop Lynparza and
selumetinib in combination with other potential new medicines and
as a monotherapy. Independently, the companies will
develop Lynparza and
selumetinib in combination with their respective PD-L1 and PD-1
medicines.
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 majority 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 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
[i] National Cancer Institute. Cancer Fact Sheet: Female
Breast Cancer. Available at
https://seer.cancer.gov/statfacts/html/breast.html Last accessed
October 2017
[ii] American Cancer Society. Breast Cancer Facts &
Figures 2015-2016. Available
Online. Accessed October 2017.
[iii] American Cancer Society. Managing Cancer as a Chronic
Illness. Available
Online. Accessed October 2017.
[iv] National Cancer Institute. BRCA1 and BRCA2: Cancer Risk
and Genetic Testing. Available
Online. Accessed October 2017.
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.
Date:
18 October 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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