AZD9291 Approved by the US FDA

TAGRISSO™ (AZD9291) APPROVED BY THE US FDA FOR patients with EGFR T790M mutation
-positive METASTATIC non-small cell lung cancer

One of fastest development programmes - from start of clinical trials to
approval in just over two and a half years to meet unmet patient need

With objective response rate of 59% and duration of response of 12.4 months,
TAGRISSO provides important new option for patients

AstraZeneca today announced that the US Food and Drug Administration (FDA) has
approved TAGRISSO™ (AZD9291) 80mg once-daily tablets for the treatment of
patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation
-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved
test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI)
therapy.

AZD9291 is the only approved medicine indicated for patients with metastatic
EGFR T790M mutation-positive non-small cell lung cancer. This indication is
approved under the FDA's accelerated approval process based on tumour response
rate and duration of response (DoR).

AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the
activating, sensitising mutations (EGFRm), and T790M, a genetic mutation
responsible for EGFR-TKI treatment resistance. Nearly two-thirds of NSCLC
patients who are EGFR mutation-positive and experience disease progression after
being treated with an EGFR-TKI develop the T790M resistance mutation, for which
there have been limited treatment options.

Pasi A Jänne MD, PhD, Director, Lowe Center for Thoracic Oncology at Dana-Farber
Cancer Institute, Scientific Director, Belfer Center for Applied Cancer Science
and Professor of Medicine, Harvard Medical School, said: "In the AURA clinical
studies, AZD9291 has demonstrated compelling early efficacy and tolerability in
patients with EGFRm T790M metastatic non-small cell lung cancer. This treatment
has the potential to become the standard of care for patients living with EGFRm
T790M non-small cell lung cancer. The accelerated approval of AZD9291 highlights
its clinical promise for a targeted group of patients and gives healthcare
providers an important new option."

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "The FDA approval of
TAGRISSO marks an important milestone for lung cancer patients who urgently need
new treatment options. We have built on our heritage in this area and acted on
the breakthrough clinical evidence to ensure this next-generation medicine
reaches patients in record time. As we advance our comprehensive lung cancer
portfolio, we have the opportunity to treat greater numbers of patients across
all stages of this disease through precision medicines, immunotherapies and
novel combinations."

AstraZeneca has collaborated with Roche to develop the cobas® EGFR Mutation Test
v2 as the companion diagnostic for AZD9291. The cobas® EGFR Mutation Test v2 is
intended to identify a range of EGFR mutations in patients with non-small cell
lung cancer, including T790M.

AZD9291 was granted Fast Track, Breakthrough Therapy, Priority Review and
Accelerated Approval status by the FDA. In Europe and Japan, AZD9291 was granted
Accelerated Assessment and Priority Review status respectively. Interactions
with regulatory authorities in the rest of the world are ongoing.

The FDA approval of AZD9291 is based on data from the two AURA Phase II studies
(AURA extension and AURA2) which demonstrated efficacy in 411 EGFRm T790M NSCLC
patients that had progressed on or after an EGFR TKI. In those trials, overall
objective response rate ((ORR) a measurement of tumor shrinkage) was 59% (95%
CI: 54% to 64%). In a supportive Phase I study in 63 patients, ORR was 51% and
median duration of response was 12.4 months.

The AZD9291 tolerability profile showed that no individual severe grade 3+
adverse events occurred at ≥ 3.5%.The most common adverse events were generally
mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4),  rash
(41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4), and
nail toxicity (25% all grades; 0% Grade 3/4). There are no contraindications for
AZD9291. Warnings and precautions include interstitial lung disease, QT interval
prolongation, cardiomyopathy and embryofoetal toxicity.



AZD9291 Development Programme

AZD9291 is being studied in the confirmatory trial, AURA3, an open label,
randomised Phase III study designed to assess the efficacy and safety of AZD9291
versus platinum-based doublet chemotherapy in patients with EGFR T790M positive,
locally advanced, or metastatic NSCLC who have progressed following prior
therapy with an EGFR-TKI. AZD9291 is also being investigated in the adjuvant
setting and in the metastatic first-line setting, including in patients with
brain metastases, as well as in combination with other compounds.

NOTES TO EDITORS

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer death among both men and women,
accounting for about one-third of all cancer deaths, more than breast, prostate
and colorectal cancers combined. Lung cancer has a five-year survival rate that
is less than 20%. Approximately 85% of all lung cancers in the US are NSCLC; 10%
to 15% of these are EGFR mutation-positive. Approximately two-thirds of patients
treated with EGFR TKI therapy will acquire resistance related to the T790M
mutation.

About AZD9291

AZD9291 80mg once-daily tablet is the first medicine indicated for the treatment
of patients with metastatic epidermal growth factor receptor (EGFR) T790M
mutation-positive non-small-cell lung cancer (NSCLC), as detected by an FDA
-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor
(TKI) therapy. Non-clinical in vitro studies have demonstrated that AZD9291 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 has recently been published by the World Health Organisation (WHO)
as the proposed International Non-proprietary Name (INN) for AZD9291, and may
become formally adopted during November 2015. In the US, the American Medical
Association accepted osimertinib as the United States Adopted Name (USAN).

About AstraZeneca in Oncology

Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It
will be potentially transformational for the company's future, becoming the
sixth growth platform. Our vision is to help patients by redefining the cancer
treatment paradigm and one day eliminate cancer as cause of death. By 2020, we
are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease
areas - lung, ovarian, breast, and hematological cancers. These are being
targeted through four key platforms - immuno-oncology, the genetic drivers of
cancer and resistance, DNA damage repair and antibody drug conjugates.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is
the world's largest biotech company, with truly differentiated medicines in
oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche
is also the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner in diabetes management. Roche's personalised
healthcare strategy aims at providing medicines and diagnostics that enable
tangible improvements in the health, quality of life and survival of patients.
Founded in 1896, Roche has been making important contributions to global health
for more than a century. Twenty-nine medicines developed by Roche are included
in the World Health Organization Model Lists of Essential Medicines, among them
life-saving antibiotics, antimalarials and chemotherapy.

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.

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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

13 NOVEMBER 2015