14th Dec 2007 10:58
GlaxoSmithKline PLC14 December 2007 Issued - Friday 14 December 2007, London, UK GLAXOSMITHKLINE RECEIVES POSITIVE EMEA OPINION FOR A CONDITIONAL APPROVAL OF TYVERB(R) Announcement signals a new way to treat advanced or metastatic ErbB2 (HER2)-positive breast cancer GlaxoSmithKline (GSK) announced today that Tyverb(R) (lapatinib) has received apositive opinion recommending a conditional marketing authorisation from theEuropean Medicines Agency (EMEA). Lapatinib, in combination with capecitabine,is indicated for the treatment of patients with advanced or metastatic breastcancer whose tumours overexpress ErbB2 (HER2). Patients should have progressivedisease following prior therapy which must include anthracyclines, taxanes andtherapy with trastuzumab in the metastatic setting. 1. Lapatinib is the first oral, small molecule dual targeted therapy that works bygetting inside the cancer cell to inhibit both ErbB1 (EGFR) and ErbB2 (HER2),two receptor proteins which are responsible for tumour growth. 2 This novelmechanism of action is a new way to treat breast cancer. "This positive opinion is fantastic news for eligible women with ErbB2-positivebreast cancer across the European Union. Thousands of women are diagnosed everyyear in Europe with ErbB2 positive breast cancer and are at a greater risk ofdisease progression and death compared to women with tumours that do notoverexpress this protein," said Dr Martine Piccart, Professor of Oncology,Universite Libre de Bruxelles and Department Head, Medicine, Jules BordetInstitute, Brussels. "Lapatinib represents an important new treatment option fora group of patients in real need of alternative therapies and I look forward tothe day that I can prescribe lapatinib. Not only that, but this is just thebeginning given the ongoing clinical programme investigating the potential useof lapatinib in earlier stages of the disease." The Data Submitted The positive opinion was based on a pivotal Phase III trial (EGF100151) in whichwomen with advanced or metastatic ErbB2-positive breast cancer whose disease hadprogressed following prior treatment were given either the combination oflapatinib and capecitabine, or capecitabine alone. The data showed that theanalysis of investigator reported median time to progression (TTP) was 23.9weeks in the lapatinib and capecitabine arm versus 18.3 weeks in thecapecitabine arm alone (hazard ratio = 0.72 p=0.00762). 3 Significance was alsoshown in the independently assessed time to progression data (hazard ratio 0.57;p=0.00013). 4, 5, 6 In addition to the achievement of the primary endpoint, results from the trialdemonstrated the associated potential to reduce the incidence of brainmetastases as the first site of recurrence in metastatic breast cancer.Progression of brain metastases was 2% in the combination arm compared with 6%in the capecitabine alone arm. 7 Central nervous system metastases are a majorburden for breast cancer patients. 8 These preliminary results with lapatinibare encouraging and are the basis of ongoing research in this area. Latest dataon the use of lapatinib and capecitabine in brain metastases will be presentedat the San Antonio Breast Cancer Symposium (SABCS) on 16 December 2007. The most common adverse events during therapy with lapatinib plus capecitabinewere gastrointestinal (diarrhoea, nausea and vomiting) or skin disorders (rashand hand and foot syndrome). The majority of adverse events were mild tomoderate in severity and were not significantly higher than those seen withcapecitabine monotherapy. 5 A conditional marketing authorisation is granted to a medicinal product thatfulfils an unmet medical need when the benefit to public health of immediateavailability outweighs the risk inherent in the fact that additional data arestill required. In the case of lapatinib, GSK is to provide further data fromthe pivotal study and also additional demonstration of decreased incidence ofrelapse in the central nervous system, for which a study will be conducted. Aconditional marketing authorisation is valid for one year. Thereafter, theconditional marketing authorisation may be renewed annually. "This is an extremely significant development for patients and physicians acrossEurope as lapatinib, in combination with capecitabine, will play a valuable rolein treating an especially aggressive form of advanced breast cancer by providingan effective treatment that offers added convenience as an oral therapy," saidPaolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centreat GSK. Andrew Witty, President, Pharmaceuticals Europe, GSK and CEO designate added,"The innovative mechanism of action of lapatinib represents a new way to treatbreast cancer patients. It is also important to note that this is GSK's secondEMEA positive opinion for a cancer treatment in a matter of months, followingthe positive opinion and approval of Atriance(R) (nelarabine) in the summer.These positive opinions underscore our commitment to develop an industry leadingoncology portfolio to address the unmet medical needs of cancer patients,whether they be for highly prevalent or extremely rare forms of the disease." Future for Lapatinib - Ongoing Clinical Trials A comprehensive clinical development programme will evaluate lapatinib bothalone and in combination with other therapies (chemotherapy, hormonal therapy,other targeted agents and VEGF inhibitors) across the spectrum of ErbB2-positivebreast cancer, from metastatic to early breast cancer. Trials are also ongoingand planned in a range of other solid tumours that overexpress ErbB1 and/orErbB2. GSK in Oncology GSK Oncology is dedicated to producing innovations in cancer that will makeprofound differences in the lives of patients. Through GSK's revolutionary 'bench to bedside' approach, we are transforming the way treatments arediscovered and developed, resulting in one of the most robust pipelines in theoncology sector. Our worldwide research in oncology includes partnerships withmore than 160 cancer centres. GSK is closing in on cancer from all sides with anew generation of patient focused cancer treatments in prevention, supportivecare, chemotherapy and targeted therapies. S M Bicknell Company Secretary 14 December 2007 About GlaxoSmithKline GlaxoSmithKline - one of the world's leading research-based pharmaceutical andhealthcare companies - is committed to improving the quality of human life byenabling people to do more, feel better, and live longer. For companyinformation, visit GlaxoSmithKline at http://www.gsk.com. Notes to editors: Tyverb(R) and Tykerb(R) are trademarks of the GlaxoSmithKline group ofcompanies.Tykerb(R) is the brand name used for lapatinib in the United States and certainother countries. Tyverb(R) is the brand name used for lapatinib in Switzerland and is theproposed trade name in the European Union, pending regulatory approval. Lapatinib is approved for sale in the United States, Australia, New Zealand,Switzerland, South Korea and certain countries in South America and the MiddleEast. Registration dossiers for lapatinib have been filed in Canada and a number ofcountries in Asia, Latin America and the Middle East. To access the latest GSK Oncology materials visit www.gskcancermedia.com Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Claire Brough (020) 8047 5502 Alice Hunt (020) 8047 5502 Joss Mathieson (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564 Sally Ferguson (020) 8047 5543 US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 References: 1. EMEA Summary of Opinion 2. Konecny GE, Pegram MD, Venkatesan N, et al. Activity of the dual kinase inhibitor lapatinib (GW572016) against HER-2-overexpressing and trastuzumab-treated breast cancer cells. Cancer Res 2006;66:1630-9 3. Tykerb(R) US Prescribing Information. GSK data on file. 4. Crown J, Cameron D, Martin AM, et al. Lapatinib plus capecitabine in HER2+ advanced breast cancer (ABC): report of updated efficacy and gene-array data. Euro J Cancer Supplements 2007; 5 (4):212: abstract O#2096 5. Geyer C, Forster J, Lindquist D, Chan S, Romieu C et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355;2733-43 6. EGF100151. A phase III, randomized, open-label, multicenter study comparing GW572016 and capecitabine (Xeloda) versus capecitabine in women with refractory advanced or metastatic breast cancer (03April2006 data cut-off) Glaxosmithkline clinical trials register 2006; Available at: http:// ctr.gsk.co.uk/Summary/lapatinib/studylist.asp. 7. Tyverb(R) Summary of Product Characteristics. GSK data on file. 8. 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 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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