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AstraZeneca: Tagrisso granted BTD designation by US FDA for the 1st-line treatment of patients with EGFR mutation-positive ...

Designation based on positive Phase III FLAURA trial results

Sixth Breakthrough Therapy Designation for an AstraZeneca New Oncology

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso
(osimertinib) for the 1st-line treatment of patients with metastatic
epidermal growth factor receptor (EGFR) mutation-positive non-small
cell lung cancer (NSCLC).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The Breakthrough Therapy
Designation acknowledges not only Tagrisso's potential as a 1st-line
standard of care in advanced EGFR mutation-positive NSCLC, but also
the significant need for improved clinical outcomes in this disease.
The results of the FLAURA trial have the potential to redefine
clinical expectations and offer new hope for patients who currently
have a poor prognosis."

The FDA granted the BTD based on data from the Phase III FLAURA trial
of Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor
(TKI) therapy in previously-untreated patients with locally-advanced
or metastatic EGFR mutation-positive NSCLC. In the trial, median
progression-free survival was nearly double at 18.9 months for
Tagrisso compared with 10.2 months for current 1st-line EGFR TKIs
(erlotinib or gefitinib). Improvements were seen in all pre-specified
subgroups, including patients with and without brain metastases.
Tagrisso was well tolerated with a safety profile consistent with
previous experience.

On 28 September 2017, the US National Comprehensive Cancer Network
Clinical Practice Guidelines in Oncology were updated to include the
use of Tagrisso in the 1st-line treatment of patients with
locally-advanced or metastatic EGFR mutation-positive NSCLC. The use
of Tagrisso for the 1st-line treatment of patients with
locally-advanced or metastatic EGFR mutation-positive NSCLC is not
yet FDA approved. However, Tagrisso is currently approved in more
than 50 countries, including the US, EU, Japan and China, as 2nd-line
treatment for patients with advanced NSCLC who progress following
treatment with an EGFR TKI due to the EGFR T790M resistance mutation.

This is the sixth BTD that AstraZeneca has received from the FDA for
an oncology medicine since 2014. BTD is designed to expedite the
development and regulatory review of new medicines that are intended
to treat a serious condition and that have shown encouraging early
clinical results, which demonstrate substantial improvement on a
clinically-significant endpoint over available medicines and when
there is significant unmet medical need.



Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-quarter of all cancer deaths, more
than breast, prostate and colorectal cancers combined. Approximately
10-15% of patients in the US and Europe, and 30-40% of patients in
Asia have EGFR-mutated NSCLC. These patients 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 EGFR TKI
treatment leading to disease progression. Approximately half of
patients develop resistance to approved EGFR TKIs such as gefitinib
and erlotinib due to the resistance mutation, EGFR T790M. Tagrisso
also targets this secondary mutation that leads to disease
progression. There is also a need for medicines with improved CNS
efficacy, since approximately 25% of patients with EGFR-mutated NSCLC
have brain metastases at diagnosis, increasing to approximately 40%
within two years of diagnosis.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI
designed to inhibit both EGFR-sensitising and EGFR T790M-resistance
mutations, with clinical activity against central nervous system
(CNS) metastases. Tagrisso 40mg and 80mg once-daily oral tablets have
been approved in more than 50 countries, including the US, EU, Japan
and China, for patients with EGFR T790M mutation-positive advanced
NSCLC. Tagrisso is also being investigated in the adjuvant setting
and in combination with other treatments.


The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg
once daily vs standard-of-care EGFR TKIs (either erlotinib [150mg
orally, once daily] or gefitinib [250mg orally, once daily]) in
previously-untreated patients with locally-advanced or metastatic
EGFR-mutated NSCLC. The trial was a double-blinded, randomised study,
with 556 patients across 30 countries.

The primary endpoint of the trial was progression-free survival (PFS),
and secondary endpoints included overall survival (OS), objective
response rate (ORR), duration of response (DOR), disease control rate
(DCR), safety, and measures of health-related quality of life

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient
with lung cancer. We have two approved medicines and a growing
pipeline that targets genetic changes in tumour cells and boosts the
power of the immune response against cancer. Our unrelenting pursuit
of science aims to deliver more breakthrough therapies with the goal
of extending and improving the lives of patients across all stages of
disease and lines of therapy.

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 investment in Acerta Pharma in

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.

Esra Erkal UK/Global +44 203 749 5638
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