LYNPARZA APPROVED BY THE US FDA


LYNPARZA™ approved by the US FOOD AND DRUG ADMINISTRATION FOR THE TREATMENT OF
ADVANCED OVARIAN CANCER IN PATIENTS WITH GERMLINE BRCA-MUTATIONS

AstraZeneca today announced that the US Food and Drug Administration (FDA) has
approved LYNPARZA™ (olaparib) capsules (400mg twice daily) as the first
monotherapy for patients with deleterious or suspected deleterious germline BRCA
-mutated (gBRCAm) advanced ovarian cancer, who have been treated with three or
more prior lines of chemotherapy. Olaparib has been approved under the FDA's
Accelerated Approval programme, based on existing objective response rate and
duration of response data. Continued approval for this indication is contingent
upon verification of clinical benefit in ongoing confirmatory Phase III trials.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour
DNA repair pathway deficiencies to preferentially kill cancer cells. It is the
first PARP inhibitor to be approved for patients with germline BRCA-mutated
advanced ovarian cancer, as detected by an FDA approved companion diagnostic
test, BRACAnalysis CDx™.

Dr. Briggs Morrison, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said "LYNPARZA is an excellent example of
how advances in the understanding of cancer biology can be used to develop the
next generation of targeted medicines. It is a much-needed new therapeutic
option for patients with germline BRCA-mutated advanced ovarian cancer. Today's
approval also marks the first of what we hope will be a number of indications in
which this medicine has the potential to improve the lives of cancer patients."

AstraZeneca filed a US regulatory submission for olaparib in February 2014,
based on data from a Phase II maintenance study1 of olaparib compared to placebo
in platinum-sensitive relapsed high grade serous ovarian cancer patients.
Following the FDA Oncologic Drugs Advisory Committee
recommendation (http://www.astrazeneca.com/Media/Press-releases/Article/25062014
--zfda-advisory-committee-votes-on-accelerated-approval) on 25 June 2014 and in
response to an FDA request for additional data, AstraZeneca submitted a major
amendment to the olaparib New Drug Application on 24 July 2014. The FDA approval
is therefore based on efficacy data from a single-arm, open-label, Phase II
study2 of olaparib in patients with deleterious or suspected deleterious
germline BRCA-mutated advanced cancers, as well as safety data from several
other olaparib studies, including the placebo-controlled study.

The efficacy of olaparib is based on analysis of 137 patients with measurable,
germline BRCA mutated advanced ovarian cancer treated with three or more prior
lines of chemotherapy. The trial results demonstrated an overall response rate
of 34% (95% Confidence Interval: 26%, 42%). The median response duration was 7.9
months (95% Confidence Interval: 5.6, 9.6 months). The most common adverse
events associated with olaparib monotherapy to date have been generally mild to
moderate and have included nausea, vomiting, fatigue and anaemia.

Dr. Ursula Matulonis, Associate Professor of Medicine, Harvard Medical School
and Director of the Gynaecological Oncology Programme at the Dana-Farber Cancer
Institute, Boston said: "Ovarian cancer is diagnosed in nearly 22,000 women per
year. The long-term survival rate in patients with advanced ovarian cancer is
10% to 30%. The FDA approval of LYNPARZA is a significant milestone for our
patients as currently there are only limited treatment options available to
women with ovarian cancer who carry the BRCA mutation."

A full review of data from either of two ongoing studies under the SOLO Phase
III clinical programme will be required for the accelerated approval of olaparib
in BRCA-mutated advanced ovarian cancer to be converted to a full approval:
SOLO2 is evaluating olaparib compared to placebo as a maintenance therapy and
SOLO3 is evaluating olaparib compared to standard chemotherapy for relapsed
disease. Data from the SOLO2 study is expected in 2015 and data from SOLO3 is
expected in 2019.

The FDA's approval follows the
announcement (http://www.astrazeneca.com/Media/Press-releases/Article/20141218-
-lynparza-approved-in-the-european-union) on 18 December of the approval of
olaparib in the European Union, as the first therapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed BRCA-mutated serous
ovarian cancer.

1 Ledermann J et al. Olaparib maintenance therapy in patients with platinum
-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis
of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncology. 2014.
http://dx.doi.org/10.1016/S1470-2045(14)70228-1

2 Kaufman B, Shapira-Frommer R, Schmultzler RK et al. Olaparib Monotherapy in
Patients With Advanced Cancer and a Germline BRCA1/2 Mutation. Journal of
Clinical Oncology 2014.
http://jco.ascopubs.org/content/early/2014/10/30/JCO.2014.56.2728

About ovarian cancer

Ovarian cancer is the fifth leading cause of cancer death among women in the
United States, mainly because it is often diagnosed late and has an extremely
poor prognosis. For the 61% of ovarian cancer patients whose cancer has
metastasised by the time of diagnosis, the five-year survival rate is only 27%.

Up to 15% of women with ovarian cancer have a BRCA mutation, which is the most
common cause of homologous repair deficiency. In BRCA-mutated tumour cells,
homologous recombination is defective and DNA double-strand break repair is
forced to occur via error-prone pathways, which can lead to genomic instability
and cell death.

About LYNPARZA™ (olaparib)

Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that exploits tumour DNA repair pathways deficiencies to
preferentially kill cancer cells. This mode of action gives olaparib the
potential for activity in a range of tumour types with DNA repair deficiencies.

Concurrent with the approval of olaparib, the FDA has approved the BRACAnalysis
CDx™ (Myriad Genetic Laboratories) for the
qualitative detection and classification of variants in the BRCA1 and BRCA2
genes.

About the Phase III SOLO programme

AstraZeneca initiated the Phase III SOLO programme in September 2013. The
programme consists of three studies:

· SOLO1: designed to evaluate olaparib as a maintenance monotherapy for ovarian
cancer in patients who have a germline BRCA mutation and who demonstrated a
complete or partial response following first-line platinum-based chemotherapy

· SOLO2: designed to evaluate olaparib as a maintenance monotherapy for relapsed
ovarian cancer in patients who have a germline BRCA mutation and who
demonstrated a complete or partial response following platinum-based
chemotherapy

· SOLO3: designed to evaluate olaparib versus non-platinum chemotherapy as third
-line or later treatment for relapsed ovarian cancer in patients who have a
germline BRCA mutation

For further information, please visit: www.ovariancancertrials.com

In addition to ovarian cancer, AstraZeneca is committed to investigating the
potential of olaparib in multiple tumour types, with Phase III studies in
adjuvant and metastatic BRCA-mutated breast cancers, BRCA-mutated pancreatic
cancer and second line gastric cancer underway.

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 cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. 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

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Michele Meixell + 1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen +44 20 7604 8199 mob: +44 7818 524185

Karl Hård +44 20 7604 8123 mob: +44 7789 654364

Eugenia Litz +44 20 7604 8233 mob: +44 7884 735627

Christer Gruvris +44 20 7604 8126 mob: +44 7827 836825

19 December 2014

-ENDS-

Attachments

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