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 April 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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25
April 2017 13:30 BST
TAGRISSO RECEIVES FULL
APPROVAL IN THE EU
Full approval follows Tagrisso's expedited Conditional Marketing
Authorisation as first-in-class medicine for patients with
locally-advanced or metastatic EGFR T790M mutation-positive
non-small cell lung cancer
Tagrisso is a potential new standard of care in 2nd line and
subsequent therapy in this hard-to-treat form of lung
cancer
Approval is based on Phase III AURA3 data which demonstrate
significant clinical superiority of Tagrisso over chemotherapy in
EGFR T790M mutation-positive NSCLC patients, including those with
CNS metastases
AstraZeneca
today announced that the European Commission (EC) has granted full
marketing authorisation for Tagrisso(osimertinib) 40mg and 80mg
once-daily tablets for the treatment of adult patients with
locally-advanced or metastatic epidermal growth factor receptor
(EGFR) T790M mutation-positive non-small cell lung cancer
(NSCLC).
The
full approval for Tagrissois based on the results of the Phase III
AURA3 trial, which were presented last year. The EGFR T790M
mutation can be detected with a validated test using either DNA
derived from a biopsy or circulating tumour DNA (ctDNA) obtained
from a plasma sample.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The full approval of
Tagrissoin the EU is further evidence of our exciting progress in
transforming the science of cancer care to deliver life-changing
medicines to people most in need. Having demonstrated its
superiority over chemotherapy in EGFR T790M mutation-positive
non-small cell lung cancer, Tagrissohas the potential to become the
new standard of care for patients with this difficult-to-treat form
of lung cancer."
Data
from the Phase III AURA3 trial showed that Tagrissodemonstrated
statistically-significant improvements in progression-free survival
(PFS) over standard platinum-based doublet chemotherapy in 419
patients with EGFR T790M-positive advanced NSCLC whose disease had
progressed on or after EGFR TKI therapy. Among patients taking
Tagrisso, the PFS was 10.1 months, compared to 4.4 months in the
chemotherapy arm. The objective response rate (ORR) was 71%
compared to 31% for chemotherapy. Among 144 patients with
metastases to the central nervous system (CNS), PFS was 8.5 months
versus 4.2 months.
The
most common adverse reactions in the Tagrissogroup were diarrhoea
(41% overall; 1% Grade ≥3), rash (34% overall; 1% Grade
≥3), dry skin (23% overall; 0% Grade ≥3), paronychia
(22% overall; 0% Grade ≥3), stomatitis (15% overall; 0% Grade
≥3, and pruritus (13% overall; 0% Grade ≥3). Warnings
and precautions include interstitial lung disease (ILD), keratitis,
left ventricular ejection fraction (LVEF) and QTc interval
prolongation.
In
March 2017, the US Food and Drug Administration (FDA) granted
Tagrissoa conversion from accelerated to full approval. Tagrissowas
also recently approved in China through the new Priority Review
Pathway, which grants an accelerated review timeline for innovative
therapies.
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, more
than breast, prostate and colorectal cancers combined. Patients who
have EGFRm NSCLC, which occurs in 10-15% of NSCLC patients in the
US and 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.
Approximately two-thirds of patients develop resistance to approved
EGFR-TKIs such as gefitinib, erlotinib and afatinib due to the
secondary mutation, T790M.
About Tagrisso
Tagrisso (osimertinib) 40mg and 80mg once-daily oral tablet
has been approved in over 45 countries, including the US, EU, Japan
and China, for patients with EGFR T790M mutation-positive advanced
NSCLC. Eligibility for treatment with Tagrisso is dependent on
confirmation that the EGFR T790M mutation is present in the
tumour.
Tagrisso is a third generation, irreversible EGFR-TKI
designed to inhibit both EGFR sensitising and EGFR T790M resistance
mutations and to have activity in the CNS.
Tagrissois
also being investigated in the adjuvant and metastatic 1st line
settings, including in patients with and without CNS metastases, in
leptomeningeal metastases, and in combination with other
treatments.
About AstraZeneca in Lung Cancer
AstraZeneca
uses ground-breaking science to develop a wide range of therapies
for patients with lung cancer. We are pioneering biomarker-guided
therapies that aim to eliminate lung cancer by targeting molecular
mutations in tumour cells and by boosting the power of the immune
response against cancer. We are committed to transforming outcomes
for patients with lung cancer, whose treatment options are
currently limited.
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 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, 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.
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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.
AstraZeneca
PLC
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Date:
25 April 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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