AstraZeneca PLC EMA accepts Tagrisso submission for 1st-line nsclc (6424X)
November 28 2017 - 1:00AM
UK Regulatory
TIDMAZN
RNS Number : 6424X
AstraZeneca PLC
28 November 2017
28 November 2017 07:00 GMT
THE EUROPEAN MEDICINES AGENCY ACCEPTS REGULATORY SUBMISSION FOR
TAGRISSO IN 1ST-LINE EGFR-MUTATED NON-SMALL CELL LUNG CANCER
Acceptance is based on positive Phase III FLAURA trial
results
AstraZeneca today announced that the European Medicines Agency
has accepted a variation to the Marketing Authorisation Application
(MAAv) for Tagrisso (osimertinib), a third-generation, irreversible
epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor
(TKI) with clinical activity against central nervous system (CNS)
metastases, for the 1st-line treatment of adult patients with
locally-advanced or metastatic non-small cell lung cancer (NSCLC)
whose tumours have EGFR mutations (exon 19 deletions or exon 21
(L858R) substitution mutations).
The MAAv submission 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.
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.
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, Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277
Adrian Kemp
Company Secretary
AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
END
REAQDLFLDFFXFBD
(END) Dow Jones Newswires
November 28, 2017 02:00 ET (07:00 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2024 to May 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From May 2023 to May 2024