Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of December
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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82-_____________
18
December 2017 07:00 GMT
US FDA ACCEPTS REGULATORY SUBMISSION FOR TAGRISSO IN 1ST-LINE EGFR-MUTATED
NON-SMALL CELL LUNG CANCER
Acceptance follows FDA Breakthrough Therapy
Designation
Tagrisso granted Priority Review
AstraZeneca
today announced that the US Food and Drug Administration (FDA) has
accepted a supplemental New Drug Application (sNDA) for the use of
Tagrisso (osimertinib), a
third-generation, irreversible epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitor (TKI) with clinical activity
against central nervous system (CNS) metastases, in the 1st-line
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumours have EGFR mutations (exon 19 deletions or
exon 21 (L858R) substitution mutations). The FDA has granted
Tagrisso Priority Review
status and previously granted Breakthrough Therapy
Designation in the 1st-line treatment of patients with
metastatic EGFR mutation-positive (EGFRm) NSCLC.
The submission acceptance is
based on data from the Phase III FLAURA trial, in which Tagrisso
significantly improved progression-free survival (PFS) compared to
current 1st-line EGFR-TKIs, erlotinib or gefitinib, in
previously-untreated patients with locally-advanced or metastatic
EGFRm NSCLC.
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
metastatic EGFRm NSCLC. The use of Tagrisso in this indication is
not yet approved by the FDA.
About NSCLC
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 EGFRm 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 CNS
metastases. Tagrisso
40mg and 80mg once-daily oral tablets have been approved in more
than 60 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.
About the FLAURA trial
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
trial, with 556 patients across 29 countries.
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 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.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
18 December 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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