IRESSA appROVED BY US FDA for FIRST-LINE treatment of
patients with ADVANCED EGFR MUTATION-POSITIVE
non-small cell lung cancer
AstraZeneca announced that the US Food and Drug Administration (FDA) has
approved IRESSA (gefitinib) tablets, 250mg once daily, for the first-line
treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose
tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon
21 (L858R) substitution mutations, as detected by an FDA-approved test.
IRESSA is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking
the activity of the EGFR tyrosine kinase enzyme responsible for regulating
signalling pathways implicated in the growth and survival of cancer cells.
IRESSA was granted Orphan Drug Designation by the FDA in August 2014 for the
treatment of EGFR mutation-positive NSCLC.
Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca
said: "The approval of IRESSA provides physicians and patients in the US with a
new choice of first-line treatment for metastatic non-small cell lung cancer.
AstraZeneca is at the forefront of research into targeted therapies for EGFR
mutated lung cancer and is committed to improving the outlook for patients at
all stages of the disease."
AstraZeneca has partnered with QIAGEN to provide the therascreen® EGFR companion
diagnostic test for IRESSA in the US. The test rapidly identifies EGFR mutation
status through a tumour tissue sample, in order to guide the use of IRESSA in
the treatment of patients with metastatic NSCLC.
The FDA approval of IRESSA is based on data from the Phase IV IFUM1 (IRESSA
Follow-Up Measure) study, assessing IRESSA as a first-line treatment for
Caucasian patients with locally advanced or metastatic EGFR mutation-positive
NSCLC. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study)
clinical trial.
IRESSA is approved in 91 countries for the treatment of adult patients with
locally advanced or metastatic EGFR mutation-positive NSCLC. The safety profile
of IRESSA is well established through a large, global clinical programme and
extensive real world evidence. The most commonly reported adverse events for
IRESSA are diarrhoea and skin reactions including rash, acne, dry skin and
pruritus.
AstraZeneca is also studying IRESSA in combination with other investigational
medicines, including the company's anti-PD-L1 monoclonal antibody, durvalumab
(MEDI4736) to assess its potential as a combination treatment for a broader
range of lung cancer patients.
1Douillard JY et al. First-line (http://www.ncbi.nlm.nih.gov/pubmed/24263064)
(http://www.ncbi.nlm.nih.gov/pubmed/24263064)gefitinib (http://www.ncbi.nlm.nih
.
gov/pubmed/24263064) (http://www.ncbi.nlm.nih.gov/pubmed/24263064)in Caucasian
EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm
study. (http://www.ncbi.nlm.nih.gov/pubmed/24263064) Br J Cancer 2014 Jan 7;
110, 55-62. doi: 10.1038/bjc.2013.721.
2 Masahiro F, et al. Biomarker analyses and final overall survival results from
a phase III, randomized, open-label, first-line study of gefitinib versus
carboplatin/paclitaxel in clinically selected patients with advanced non-small
-cell lung cancer in Asia (IPASS). J Clin Oncol 2011Jul 20; 29(21):2866-74. doi:
10.1200/JCO.2010.33.4235.
About the IFUM Study
The IFUM study was a multicentre, single arm study to characterise the efficacy
and safety of gefitinib 250mg (once daily) as first-line treatment in Caucasian
patients who have EGFR mutation-positive locally advanced or metastatic NSCLC. A
total of 106 EGFR mutation-positive patients were enrolled to the study. The
overall response rate (ORR) by investigators' assessment was 70% (95% confidence
interval (CI) 61% to 78%). ORR by a Blinded Independent Centre Review (BICR) was
50% (95% CI 41% to 59%).
The most common adverse events (AEs) in the IFUM study were rash (44.9%),
diarrhoea (30.8%), vomiting (13.1%), asthenia, cough and dry skin (all 11.2%),
and nausea (10.3%). Two patients (1.9%) experienced a serious AE that the
investigator characterised as related to treatment, and 4 patients (3.7%)
experienced drug related AEs that led to treatment discontinuation.
About IRESSA
IRESSA is a targeted monotherapy for the treatment of patients with advanced or
metastatic epidermal growth factor receptor mutation-positive non-small cell
lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the
EGFR, thus blocking the transmission of signals involved in the growth and
spread of tumours. EGFR mutations occur in approximately 10 to 15 percent of
NSCLC Caucasian patients and 30 to 40 percent of NSCLC patients in Asia.
IRESSA is approved in 91 countries worldwide.
In the US, AstraZeneca has partnered with QIAGEN to develop a companion
diagnostic test to guide the use of IRESSA. In Europe, the collaboration between
AstraZeneca and QIAGEN has resulted in IRESSA becoming the first EGFR tyrosine
kinase inhibitor to have a European label supporting the use of circulating
tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment
of EGFR mutation status in those patients where a tumour sample is not an
option.
About AstraZeneca in Oncology
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It
will be potentially transformational for the company's future, becoming the
sixth growth platform. Our vision is to help patients by redefining the cancer
treatment paradigm and one day eliminate cancer as cause of death. By 2020, we
are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on four main disease
areas - lung, ovarian, breast, and haematological cancers. These are being
targeted through four key platforms - immuno-oncology, the genetic drivers of
cancer and resistance, DNA damage repair and antibody drug conjugates.
In lung cancer, AstraZeneca is at the forefront of development of targeted
therapies, with more than 10 years' experience in providing treatments for this
challenging disease. In 2002, AstraZeneca was the first company to launch an
EGFR TKI for patients with pre-treated metastatic NSCLC. We are committed to
addressing the urgent unmet need for more effective treatments and are
developing therapies that target all stages of the disease from primary
treatment through to recurrence and re-treatment, in order to achieve sustained
disease control. By making targeted, personalised treatment a reality at every
stage, we hope to take important steps towards ultimately eradicating death from
lung cancer.
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 cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. 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
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14 July 2015
-ENDS-
IRESSA approved by US FDA
| Source: AstraZeneca PLC
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