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GLAXOSMITHKLINE RECEIVES MARKETING AUTHORISATION
IN THE EU FOR TYVERB® (LAPATINIB),
THE FIRST ORAL TARGETED THERAPY FOR ERBB2-POSITIVE
BREAST CANCER
GlaxoSmithKline announced today that the European Commission has granted a conditional
marketing authorisation for Tyverb® (lapatinib), the first oral, small molecule dual targeted
therapy, for all 27 European Union member states. Lapatinib, in combination with
capecitabine, is indicated for the treatment of patients with advanced or metastatic breast
cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease
following prior therapy, which must include anthracyclines and taxanes, and therapy with
trastuzumab in the metastatic setting.1
Today’s news means that GSK is able to make lapatinib available in the European Union
(subject to market access requirements) and the company is currently working with local
regulatory authorities to ensure lapatinib is available to eligible patients as soon as possible.
Lapatinib has a novel mechanism of action that is different from current licensed targeted
therapies for ErbB2-positive disease. It is a small molecule that is administered orally and
works by getting inside the cancer cell and inhibiting two receptor proteins – the tyrosine
kinase components of the ErbB1 and ErbB2 receptors. The signalling of these receptors is
responsible for tumour growth and proliferation.2,3
"Today’s news will benefit women across Europe with HER2-positive advanced or metastatic
breast cancer which needs further treatment after the previous standard treatments of
anthracyclines, taxanes, and trastuzumab. Lapatinib will play a valuable role in treating this
especially aggressive form of advanced breast cancer, with the added benefit of convenience
being a pill rather than needing intravenous administration” said Professor David Cameron,
Co-Principle Investigator of the Phase III trial (EGF100151) and Director of National Cancer
Research Network; Chair, Medical Oncology, Faculty of Medicine and Health, University of
Leeds.
"This news signifies a genuine advancement in the treatment of ErbB2-positive breast cancer.
These patients are in real need of alternative therapies and we at GSK are proud to make this
important new treatment option available to them," said Dr. Paolo Paoletti, SVP and Global
Head of the Oncology Medicine Development Centre at GSK. "The authorisation of lapatinib
demonstrates our strong commitment to the discovery and development of novel anti-cancer
treatments. With numerous clinical trials assessing lapatinib across a range of tumour types,
we hope this is just the beginning for this innovative product, in terms of the positive
difference it can make to patients’ lives.”
The Data Submitted
The authorisation was based on a pivotal Phase III trial (EGF100151) in which women with
locally advanced or metastatic ErbB2-positive breast cancer whose disease had progressed
following prior treatment with anthracyclines, taxanes and trastuzumab were given either the
combination of lapatinib and capecitabine, or capecitabine alone. The data showed that the
investigator assessed median time to progression was 5.5 months (23.9 weeks) in the
lapatinib and capecitabine arm versus 4.2 months (18.3 weeks) in the capecitabine arm alone
(hazard ratio 0.72; p=0.008).1 The independent assessment demonstrated that lapatinib when
given in combination with capecitabine significantly increased time to progression by 6.2
months (27.1 weeks) compared to 4.3 months (18.6 weeks) with capecitabine alone (hazard
ratio 0.57 p=0.001).4
Central nervous system metastases are a major burden for breast cancer patients. 5 In
addition to the achievement of the primary endpoint in the pivotal Phase III trial, results from
an unplanned retrospective exploratory analysis demonstrated a reduced incidence of brain
metastases as the first site of disease recurrence. In this retrospective exploratory analysis,
2% of patients in the combination arm had relapse to the brain compared with 6% in the
capecitabine alone arm.1
These preliminary results with the addition of lapatinib are
encouraging and are the basis of ongoing research in this area.
The most common adverse events during therapy with lapatinib plus capecitabine during the
pivotal Phase III trial were gastrointestinal (diarrhoea, nausea and vomiting) or skin disorders
(rash and hand and foot syndrome).1 Diarrhoea and rash were more common with the
combination than with capecitabine alone.4 The majority of adverse events were mild to
moderate in severity, and the incidence of grade 3 and 4 events was low and similar in both
treatment groups.4 Lapatinib has also been associated with reports of decreases in left
ventricular ejection fraction (LVEF), pulmonary toxicity and hepatotoxicity. Advice to doctors is
contained in the prescribing information.1
A conditional marketing authorisation is granted to a medicinal product with a positive
benefit/risk assessment that fulfils an unmet medical need when the benefit to public health of
its immediate availability outweighs the risk inherent in the fact that additional data are still
required. A conditional marketing authorisation is renewable annually. As part of the
conditions of the conditional marketing authorisation, GSK will provide further data from the
pivotal study, and also conduct an additional clinical study.
Future for Lapatinib - Ongoing Clinical Trials
A comprehensive clinical development programme is evaluating lapatinib both alone and in
combination with other therapies (chemotherapy, hormonal therapy, other targeted agents and
VEGF inhibitors) across the spectrum of ErbB2-positive breast cancer, from metastatic to early
breast cancer.
Trials are also ongoing and planned in a range of other solid tumours that
overexpress ErbB1 and/or ErbB2 including gastric and head and neck cancer.
GSK in Oncology
GSK Oncology is dedicated to producing innovations in cancer that will make profound
differences in the lives of patients. Through GSK’s revolutionary ‘bench to bedside’ approach,
we are transforming the way treatments are discovered and developed, resulting in one of the
most robust pipelines in the oncology sector. Our worldwide research in oncology includes
partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides
with a new generation of patient focused cancer treatments in prevention, supportive care,
chemotherapy and targeted therapies.
About GlaxoSmithKline
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare
companies – is committed to improving the quality of human life by enabling people to do
more, feel better, and live longer. For company information, visit GlaxoSmithKline at
http://www.gsk.com.
Notes to editors:
Tykerb® is the brand name used for lapatinib in the United States and certain other countries.
Tyverb® is the brand name used for lapatinib in Switzerland and in the European Union.
Tyverb® and Tykerb® are trademarks of the GlaxoSmithKline group of companies.
Tykerb® is authorised for sale in the United States and in certain other countries.
Tyverb® is authorised for sale in the European Union and Switzerland.
Registration dossiers for lapatinib have been filed in Canada and a number of countries in
Asia, Latin America and the Middle East.
To access the latest GSK Oncology materials for media, visit www.gskcancermedia.com
Enquiries:
[Insert details of local media enquires and analyst / investor relations contacts]
References
1
2
3
4
5
Tyverb Summary of Product Characteristics.
Spector NL, Xia W, Burris H, 3rd, et al. Study of biologic effects of lapatinib, a reversible inhibitor of ErbB1 and
ErbB2 tyrosine kinases on tumor growth and survival pathways in patients with advanced malignancies. JClin
Oncol 2005; 23 (11);2502-12.
Rusnak DW, Lackey K, Affleck K, et al. The effects of the novel, reversible epidermal growth factor /ErbB-2
tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in
vivo. Mol Cancer Ther 2001:1(2):85-94.
Cameron D, Casey M, Press M et al. A phase III randomized comparison of lapatinib plus capecitabine versus
capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated
efficacy and biomarker analyses. Breast Cancer Res Treat 2008; [Epub ahead of print]
Pelletier EM, Shim B, Goodman S, Amonkar MM. Epidemiology and economic burden of brain metastases
among patients with primary breast cancer: results from a US claims data analysis. Breast Cancer Res Treat
2007.