Du är här

2016-02-03

AstraZeneca: Tagrisso™ approved in EU as first-in-class treatment for patients with EGFR T790m mutation-positive metastatic non-small cell lung cancer

TAGRISSO™ is the first new medicine to be approved under the European
Commission's expedited process

Approval based on studies showing objective response rate of 66% and
median progression-free survival of 9.7 months

Tumour sample or blood test can determine patients likely to benefit
from osimertinib

AstraZeneca today announced that the European Commission (EC) has
granted conditional marketing authorisation for TAGRISSO™ (AZD9291,
osimertinib) 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).

Osimertinib is indicated for patients with T790M mutation-positive
NSCLC, irrespective of previous treatment with an EGFR tyrosine
kinase inhibitor (TKI). Eligibility for treatment with osimertinib
will be dependent on mutation status, to be determined through a
validated diagnostic test based on a tumour tissue sample or plasma.
Availability of a blood-based test for circulating tumour DNA (ctDNA)
means that physicians and patients have multiple options to test for
a T790M mutation.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "Osimertinib defines a
new generation of targeted EGFR-TKI treatments, and the European
Commission's expedited approval reflects the importance of this
innovative medicine for addressing the needs of patients with lung
cancer who have the T790M mutation. We are now building on our
understanding of the clinical activity of osimertinib to explore its
full potential in patients with EGFRm lung cancer in multiple
treatment settings."

Dr Matthew Peters, Chair of the Global Lung Cancer Coalition, added:
"It is an exciting time in the care of patients with lung cancer. The
ability to precisely characterise patients who have different types
of lung cancer based on genetic mutations, and predict their response
to targeted treatments, offers a more accurate and efficient approach
to lung cancer care. Patients with common sensitising EGFR mutations
and the separate T790M have disappointing responses to standard
treatments. Testing for the T790M status of lung cancer patients,
using either a tumour sample or a simple blood test, and directing
patients towards a medication such as osimertinib that is
specifically designed for their pattern of mutations, offers greater
prospects for durable treatment outcomes."

Mutations in the EGFR receptor can lead to uncontrolled cell growth
and tumour formation. Osimertinib targets both the EGFR mutation that
triggers cancer development and T790M, a mutation that makes tumours
resistant to existing treatment with EGFR-TKIs. Nearly two out of
three patients with NSCLC whose disease progresses after treatment
with an EGFR inhibitor develop the T790M mutation, for which
treatment options are limited. A small number of patients
(approximately 3-5%) have the T790M mutation at NSCLC diagnosis.

The EU approval for osimertinib is based on data from two Phase II
studies (AURA extension and AURA2) and the AURA Phase I expansion
study, which demonstrated efficacy in 474 patients with EGFRm T790M
NSCLC who had progressed on or after an EGFR-TKI. In the combined
Phase II studies, the objective response rate (ORR, a measurement of
tumour shrinkage) was 66%, and in the Phase I study it was 62%.
Progression-free survival (PFS) was 9.7 months in the combined Phase
II studies and 11 months in the Phase I trial. Median duration of
response (DOR) in the Phase I study was 9.7 months, and in the
combined Phase II studies, median DOR was not reached.

The most common adverse events based on data from the two AURA Phase
II studies were generally mild to moderate and included diarrhoea
(42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade
3/4), dry skin (31% all grades; 0% Grade 3/4) and nail toxicity (25%
all grades; 0% Grade 3/4). Warnings and precautions include
interstitial lung disease and QT interval prolongation.

The EU marketing authorisation was received through the Accelerated
Assessment procedure of the European Medicines Agency (EMA). This
approval follows US Accelerated Approval granted in November 2015 and
availability in the UK under the Early Access to Medicines Scheme in
December 2015. In Japan, osimertinib was granted Priority Review by
the Pharmaceuticals and Medical Devices Agency (PMDA). Interactions
with regulatory authorities in the rest of the world are ongoing.

NOTES TO EDITORS

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. Patients who
have the EGFRm form of NSCLC, which occurs in 10-15%of NSCLC patients
in Europeand 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. In approximately
two-thirds of patients treated with the approved EGFR-TKIs,
gefitinib, erlotinib or afatinib, this resistance is caused by the
secondary mutation, T790M.

About osimertinib

Osimertinib 80mg once-daily tablet is the first medicine indicated for
the treatment of adult patients with metastatic EGFR T790M
mutation-positive NSCLC. Non-clinical in vitro studies have
demonstrated that osimertinib has high potency and inhibitory
activity against mutant EGFR phosphorylation across the range of
clinically relevant EGFRm and T790M mutant NSCLC cell lines with
significantly less activity against EGFR in wild-type cell lines.

Osimertinib is being compared with platinum-based doublet chemotherapy
in the confirmatory AURA3 Phase III study in patients with EGFR
T790M-positive, locally advanced or metastatic NSCLC who have
progressed after EGFR-TKI therapy. It is also being investigated in
the adjuvant and metastatic first-line settings, including in
patients with brain metastases, and in combination with other
compounds.

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 6
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, the genetic drivers of cancer and resistance, DNA
damage repair 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, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - respiratory, inflammation, autoimmune
disease (RIA), cardiovascular and metabolic disease (CVMD) and
oncology - as well as in infection and neuroscience. 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

CONTACTS

Media Enquiries
Esra Erkal-Paler UK/Global +44 20 7604 8030
Neil Burrows UK/Global +44 20 7604 8032
Vanessa Rhodes UK/Global +44 20 7604 8037
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen Oncology +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
Christer Gruvris Consensus Forecasts +44 7827 836825
US
Lindsey Trickett Oncology, ING +1 240 543 7970
Mitch Chan Oncology +1 240 477 3771
Dial / Toll-Free +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD -
Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

-----------------------------------------------------------
http://news.cision.com/se/astrazeneca/r/tagrisso-approved-in-eu-as-first...

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.