<SEC-DOCUMENT>0001654954-21-004150.txt : 20210414
<SEC-HEADER>0001654954-21-004150.hdr.sgml : 20210414
<ACCEPTANCE-DATETIME>20210414062322
ACCESSION NUMBER:		0001654954-21-004150
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210414
FILED AS OF DATE:		20210414
DATE AS OF CHANGE:		20210414

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		21824480

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a4184v.htm
<DESCRIPTION>TAGRISSO APPROVED IN CHINA IN EARLY LUNG CANCER
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Tagrisso approved in China in early lung cancer</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
14 April 2021 07:00 BST</font></div>
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&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;approved in China for the adjuvant
treatment</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
of&#xA0;patients with early-stage EGFR-mutated lung
cancer</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Tagrisso is the only targeted medicine to show efficacy in the
treatment of early-stage lung cancer in a global trial and the
first such medicine approved in China</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Approval based on unprecedented results from the ADAURA Phase III
trial</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
where Tagrisso reduced the risk of disease recurrence or death by
80%</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;(osimertinib) has been approved in China for
the adjuvant treatment of patients with early-stage (IB, II and
IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small
cell lung cancer (NSCLC) after tumour resection with curative
intent, with or without adjuvant chemotherapy as recommended by the
patient's physician.&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;is indicated for EGFRm patients whose
tumours have exon 19 deletions or exon 21 (L858R)
mutations.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The&#xA0;approval by China's&#xA0;National Medical Products
Administration (NMPA)&#xA0;was based on positive results from the
ADAURA Phase III trial. In the trial,&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival (DFS) in
the primary analysis population of patients with Stage II and IIIA
EGFRm NSCLC. The ADAURA trial also showed a statistically
significant and clinically meaningful improvement in DFS in the
overall trial population of patients with Stage IB-IIIA disease, a
key secondary endpoint.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
While up to 30% of all patients with NSCLC may be diagnosed early
enough to have surgery with curative intent, recurrence is still
common in early-stage disease. Historically, nearly half of
patients diagnosed in Stage IB, and over three quarters of patients
diagnosed in Stage IIIA, have experienced recurrence within five
years.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1-3</font><font style="color: #000000">&#xA0;More
than a third of the world's lung cancer patients are in China and
among those with NSCLC, approximately 40% have tumours with an EGFR
mutation.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4-6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "The expedited approval of&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;in China as part of a curative-intent
regimen for early-stage EGFR-mutated lung cancer underscores the
high unmet need in this setting and our commitment to improving
outcomes in a country with one of the highest rates of EGFR
mutations in the world. This approval reinforces the importance of
EGFR testing across all stages of lung cancer, prior to treatment
decisions, to ensure as many patients as possible can benefit from
targeted therapies like&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;and live cancer-free
longer."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In the ADAURA trial, adjuvant treatment
with&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;reduced the risk of disease recurrence or
death by 83% in patients with Stage II and IIIA
disease&#xA0;(hazard ratio [HR] 0.17; 99.06% confidence interval
[CI] 0.11-0.26; p&lt;0.001) and by 80% in the overall trial
population of patients with Stage IB-IIIA disease (HR 0.20; 99.12%
CI 0.14-0.30; p&lt;0.001).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Consistent DFS results were seen regardless of prior adjuvant
chemotherapy use and across all prespecified subgroups, including
in Asian and non-Asian patients. The safety and tolerability
of&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;in this trial&#xA0;was consistent with
previous trials in the metastatic setting. The ADAURA results were
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Tagrisso</font><font style="color: #000000">&#xA0;is approved to
treat early-stage lung cancer in more than a dozen countries,
including&#xA0;</font><font style="text-decoration: underline; color: #0000FF">the
US</font><font style="color: #000000">, and additional global
regulatory reviews are ongoing.&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;is also approved for the 1st-line treatment
of patients with locally advanced or metastatic EGFRm NSCLC and for
the treatment of locally advanced or metastatic EGFR T790M
mutation-positive NSCLC in China, and in the US, Japan, the EU and
many other countries.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
This approval follows a priority review designation by the NMPA's
Center for Drug Evaluation. It marks the third approved indication
for&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;in China following previous approvals in
2nd-line T790M and 1st-line EGFRm NSCLC, which are both included on
the National Reimbursement Drug List.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Lung cancer</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;Lung
cancer is broadly split into NSCLC and small cell lung cancer, with
80-85% classified as NSCLC.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7&#xA0;</font><font style="color: #000000">The
majority of NSCLC patients are diagnosed with advanced disease
while approximately 25-30% present with
resectable&#xA0;disease&#xA0;at diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1-2</font><font style="color: #000000">&#xA0;Early-stage
lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.</font><font style="font-size: 70%; vertical-align: top; color: #000000">8-9</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
For patients with resectable tumours, the majority of patients
eventually develop recurrence despite complete tumour resection and
adjuvant chemotherapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10-12</font><font style="color: #000000">&#xA0;These
patients are particularly sensitive to treatment with an
EGFR-tyrosine kinase inhibitor (TKI) which blocks the
cell-signalling pathways that drive the growth of tumour
cells.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13</font></font></div>
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ADAURA is a randomised, double-blind, global, placebo-controlled
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Stage IB, II and IIIA EGFRm NSCLC following complete tumour
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and the Middle East. The primary endpoint was DFS in Stage II and
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and IIIA patients.</font></div>
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Tagrisso</font><font style="color: #000000">&#xA0;(osimertinib) is
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tablets)&#xA0;has been used to treat approximately 250,000 patients
across indications worldwide and&#xA0;AstraZeneca continues to
explore&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;as a treatment for patients across multiple
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advanced unresectable setting (LAURA), in the neoadjuvant
resectable setting (NeoADAURA) and in combination with chemotherapy
(FLAURA2).&#xA0;AstraZeneca is also researching ways to address
tumour mechanisms of resistance through the SAVANNAH and ORCHARD
Phase II trials, which test&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;given concomitantly with savolitinib, an
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References</font></div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Cagle P,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Lung Cancer Biomarkers: Present Status and
Future Developments.&#xA0;</font><font style="font-style: italic; color: #000000">Archives Pathology Lab
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<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Le Chevalier T. Adjuvant Chemotherapy for
Resectable Non-Small-Cell Lung Cancer: Where is it
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">3.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Pignon&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Lung Adjuvant Cisplatin Evaluation: A Pooled
Analysis by the LACE Collaborative Group.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Oncol</font><font style="color: #000000">&#xA0;2008;26:3552-3559.</font></font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">4.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">World
Health Organization. International Agency for Research on Cancer.
Lung Fact Sheet. Available at
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed April 2021.</font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">5.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">World
Health Organization. International Agency for Research on Cancer.
Globocan China Fact Sheet 2020. Available at
http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed April 2021.</font></div>
</div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">6.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Zhang, Y.L.,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;The prevalence of EGFR mutation in patients
with non-small cell lung cancer: a systematic review and
meta-analysis.&#xA0;</font><font style="font-style: italic; color: #000000">Oncotarget.</font><font style="color: #000000">&#xA0;2016; 7(48):
78985-78993.</font></font></div>
</div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">7.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">LUNGevity
Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed April 2021.</font></div>
</div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">8.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Sethi S,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Incidental Nodule Management - Should There
Be a Formal Process?.&#xA0;</font><font style="font-style: italic; color: #000000">Journal of Thorac
Onc</font><font style="color: #000000">.
2016:8;S494-S497.</font></font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">9.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">LUNGevity
Foundation. Screening and Early Detection. Available at
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Accessed April 2021.</font></div>
</div>
</div>
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<div style="display: table-row">
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">10.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Szumera-Cie&#x107;kiewicz
A,&#xA0;</font><font style="font-style: italic; color: #000000">et
al.</font><font style="color: #000000">&#xA0;EGFR Mutation Testing
on Cytological and Histological Samples in Non-Small Cell Lung
Cancer: a Polish, Single Institution Study and Systematic Review of
European Incidence.&#xA0;</font><font style="font-style: italic; color: #000000">Int J Clin Exp
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">11.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Keedy V.L.,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Oncol</font><font style="color: #000000">.
2011:29;2121-27.</font></font></div>
</div>
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">12.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Ellison G,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Pathol.</font><font style="color: #000000">&#xA0;2013:66;79-89.</font></font></div>
</div>
</div>
<div style="margin-left: 24px; display: table">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">13.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Cross DA,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;AZD9291, an Irreversible EGFR TKI, Overcomes
T790M-Mediated Resistance to EGFR Inhibitors in Lung
Cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Cancer
Discov</font><font style="color: #000000">.
2014;4(9):1046-1061.</font></font></div>
</div>
</div>
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Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
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