TIDMAZN
RNS Number : 1313B
AstraZeneca PLC
31 March 2017
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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