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 October
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
9 October 2017 07:00 BST
TAGRISSO
GRANTED BREAKTHROUGH THERAPY
DESIGNATION BY US FDA FOR THE 1ST-LINE TREATMENT OF PATIENTS WITH
EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG
CANCER
Designation based on positive Phase III FLAURA trial
results
Sixth Breakthrough Therapy Designation for an AstraZeneca New
Oncology medicine
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.
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 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.
About FLAURA
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
(HRQoL).
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 main 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.
|
Media
Relations
|
|
|
|
Esra
Erkal-Paler
|
UK/Global
|
+44 203
749 5638
|
|
Karen
Birmingham
|
UK/Global
|
+44 203
749 5634
|
|
Rob
Skelding
|
UK/Global
|
+44 203
749 5821
|
|
Matt
Kent
|
UK/Global
|
+44 203
749 5906
|
|
Gonzalo
Viña
|
UK/Global
|
+44 203
749 5916
|
|
Jacob
Lund
|
Sweden
|
+46
8 553 260 20
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Craig
Marks
|
Finance,
Fixed Income, M&A
|
+44
7881 615 764
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Mitchell
Chan
|
Oncology
|
+1 240
477 3771
|
|
Christer
Gruvris
|
Diabetes;
Autoimmunity, Neuroscience & Infection
|
+44 203
749 5711
|
|
Nick
Stone
|
Respiratory;
Brilinta
|
+44 203
749 5716
|
|
US toll
free
|
|
+1 866
381 7277
|
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:
09 October 2017
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|