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 March 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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12g3-2(b): 82-_____________
31 March 2017 07:00 BST
TAGRISSO (OSIMERTINIB)
RECEIVES US FDA FULL APPROVAL
Conversion from accelerated
to full approval confirms the potential of Tagrisso to become
standard of care in the US
Approval based on Phase III AURA3 trial that demonstrated
significant improvement in progression-free survival with Tagrisso
as compared to chemotherapy
AstraZeneca
today announced that the US Food and Drug Administration (FDA) has
granted full approval for Tagrisso (osimertinib) 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,
whose disease has progressed on or after an EGFR tyrosine kinase
inhibitor (TKI) therapy. Tagrisso is the first and only approved
medicine in the US indicated for NSCLC patients who have tested
positive for the EGFR T790M mutation, and efficacy data suggest it
may be a new standard of care for these patients.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "By following the
science, we aim to turn lung cancer into a chronic, manageable
disease for patients and this milestone brings us one step closer
to that ambition. The FDA's full approval reinforces the
potential of Tagrisso
to become the standard of care for patients with metastatic EGFR
T790M mutation-positive non-small cell lung cancer whose disease
has progressed on or after first-generation EGFR-TKI
therapy."
The
full approval in the US is based on data from the randomised, Phase
III AURA3 trial, in which Tagrisso significantly improved
progression-free survival (PFS) versus platinum-based doublet
chemotherapy, providing 10.1 months of median PFS compared to 4.4
months from chemotherapy (hazard ratio 0.30; 70% risk reduction;
95% Confidence Interval [CI]: 0.23; 0.41; P<0.001). The results
of this trial were recently presented at the 17th World Conference
on Lung Cancer (WCLC) in Vienna, Austria, and published in
The New England Journal of
Medicine.
In
AURA3 the most common (>20%) adverse reactions observed in
Tagrisso-treated patients
were diarrhea (41%), rash (34%), dry skin (23%), nail toxicity
(22%), and fatigue (22%). Dose reductions occurred in 2.9% of
patients treated with Tagrisso. The most frequent adverse
reactions that led to dose reductions or interruptions were
prolongation of the QT interval as assessed by ECG (1.8%),
neutropenia (1.1%), and diarrhea (1.1%). Serious adverse reactions
were reported in 18% of patients treated with Tagrisso and 26% of patients in the
chemotherapy group. No single serious adverse reaction was reported
in 2% or more patients treated with Tagrisso.
Tagrisso was granted Fast Track, Breakthrough Therapy
and Priority Review designations by the US FDA, and received
Accelerated Approval for this indication in 2015 based on tumour
response rate and duration of response.
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 and more
than breast, prostate and colorectal cancers combined. Among
patients with NSCLC, 20% to 40% have brain metastases at some time
during the course of their disease. Patients who have the EGFRm
form of 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 and erlotinib 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 non-small cell lung cancer (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
tyrosine kinase inhibitor designed to
inhibit both EGFR sensitising and EGFR T790M resistance mutations
and to have activity in the central nervous system
(CNS). Tagrisso is
also being investigated in the adjuvant and metastatic first-line
settings, including in patients with and without CNS metastases, in
leptomeningeal metastases, and in combination with other
treatments.
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
Date:
31 March 2017
|
By: /s/
Adrian Kemp
|
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Name:
Adrian Kemp
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Title:
Company Secretary
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