TIDMAZN
RNS Number : 8809T
AstraZeneca PLC
18 October 2017
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.
Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
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Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Christer Gruvris Diabetes; Autoimmunity, Neuroscience & Infection +44 203 749 5711
Nick Stone Respiratory; Brilinta +44 203 749 5716
US toll free +1 866 381 7277
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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