TAGRISSO APPROVED IN JAPAN FOR CANCER PATIENTS

TAGRISSO™ (OSIMERTINIB) approved in japan for PATIENTS WITH EGFR T790M mutation
-positive metastatic non-small cell lung cancer

Full approval is based on two Phase II trials, AURA extension and AURA2,
demonstrating objective response rates of 61.3% and 70.9%, respectively

Osimertinib targets mutation seen in significant proportion of patients with
lung cancer in Japan

Japanese and recent US and EU approvals for osimertinib achieved within three
years of clinical trials initiation

AstraZeneca today announced that the Japanese Ministry of Health, Labour and
Welfare (MHLW) has approved Tagrisso (osimertinib, AZD9291) 80mg once-daily
tablets for the treatment of patients with epidermal growth factor receptor
(EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung
cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI)
therapy.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "We continue to move at an unprecedented
pace with osimertinib, with the full approval in Japan following closely the
recent US and EU approvals. As first-in-class lung cancer treatment directed at
the T790M mutation, we are delighted that this targeted medicine is now
available to patients in Japan to address the existing unmet medical need."

Dr. Tetsuya Mitsudomi, Division of Thoracic Surgery, Department of Surgery,
Kinki University Faculty of Medicine said: "A significant proportion of Japanese
patients with lung cancer have the EGFR mutation and about 60% of them are
likely to develop the T790M resistance mutation following initial TKI treatment.
Osimertinib enables us to respond to this disease progression in a precise and
logical way as clearly demonstrated in clinical trials, with potential to make a
meaningful difference to the lives of Japanese patients."

Approximately 30-40% of Asian patients with NSCLC have the EGFR mutation at
diagnosis. Nearly two out of three patients with NSCLC whose disease progresses
after treatment with an EGFR-TKI develop the T790M mutation, for which treatment
options are currently limited. Osimertinib targets both the EGFR mutation
involved in cancer development and T790M, a mutation that makes tumours
resistant to existing treatment with EGFR-TKIs. Patients with EGFRm NSCLC, who
experience disease progression, should be tested for their mutation status
through a validated diagnostic test. AstraZeneca has collaborated with Roche to
develop the cobas® EGFR Mutation Test v2 as the companion diagnostic for
osimertinib.

The Japanese approval is based on data from the two multinational AURA Phase II
trials (AURA extension and AURA2), with 22% of patients enrolled from Japan. The
studies demonstrated efficacy in patients who had progressed on or after
treatment with an EGFR-TKI and whose tumours tested positive for the EGFR T790M
mutation. The overall objective response rate (ORR, a measurement of tumour
shrinkage) was 61.3% (95% CI: 54.2% to 68.1%) in AURA extension (n=199), and
70.9% (95% CI: 64.0% to 77.1%) in AURA2 (n=199) (1 May 2015 cut-off).

In the two AURA Phase II studies (n=411), the most commonly reported adverse
events assessed by the investigator were rash/acne (37.7%), diarrhoea (36.5%),
dry skin/eczema, etc. (28.5%), nail disorder including paronychia, etc (23.4%).
In Japanese patients (n=80), the incidence of interstitial lung disease (ILD;
including pneumonitis etc.), as assessed by the investigator, for all grades was
6.3% (1 May 2015 cut-off). Warnings and precautions include ILD, QT interval
prolongation, hepatic impairment and haematological changes.

AstraZeneca has agreed a Risk Management Plan with the Japanese Health
Authority.

The full Japanese approval was granted seven months after the New Drug
Application submission in August 2015.  The Japanese approval for osimertinib
was granted under the Priority Review mechanism of the MHLW, in recognition of
the submitted data and the life-threatening nature of the disease. The Japanese
approval follows US FDA Accelerated Approval in November 2015 and European
Commission conditional marketing authorisation in February 2016. Interactions
with regulatory authorities in the rest of the world are ongoing.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the leading cause of cancer death among both men and women,
accounting for about one-third of all cancer deaths, and more than breast,
prostate and colorectal cancers combined. Patients who have the EGFRm form of
NSCLC, which occurs in 10-15% of NSCLC patients in Europe and 30-40% of NSCLC
patients in Asia, are particularly sensitive to treatment with currently
available EGFR-TKIs, which block the cell signalling pathways that drive the
growth of tumour cells. However, tumours almost always develop resistance to
treatment, leading to disease progression. In approximately two-thirds of
patients treated with the approved EGFR-TKIs, gefitinib, erlotinib or afatinib,
this resistance is caused by the secondary mutation, T790M.

About osimertinib

Osimertinib 80mg once-daily tablet is the first medicine indicated for the
treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC.
Non-clinical in vitro studies have demonstrated that osimertinib has high
potency and inhibitory activity against mutant EGFR phosphorylation across the
range of clinically relevant EGFRm and T790M mutant NSCLC cell lines, with
significantly less activity against EGFR in wild-type cell lines.

Osimertinib is being compared with platinum-based doublet chemotherapy in the
confirmatory AURA3 Phase III trial in patients with EGFR T790M-positive, locally
advanced or metastatic NSCLC who have progressed after EGFR-TKI therapy. It is
also being investigated in the adjuvant and metastatic first-line settings,
including in patients with brain metastases, and in combination with other
compounds.

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 repair 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

CONTACTS

Media Enquiries
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Michele Meixell      US                   +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen                       +44 7818 524185
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US
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

29 March 2016

-ENDS-