14th Mar 2007 07:00
GlaxoSmithKline PLC13 March 2007 Issued - Tuesday 13 March 2007, London, UK FDA APPROVES GLAXOSMITHKLINE'S NEW ORAL BREAST CANCER TREATMENT TYKERB(R)(LAPATINIB) GlaxoSmithKline plc (LSE: GSK, NYSE: GSK) announced today that the United StatesFood and Drug Administration (FDA) approved TYKERB(R) (lapatinib), incombination with Xeloda(R) (capecitabine), for the treatment of patients withadvanced or metastatic breast cancer whose tumours overexpress HER2 and who havereceived prior therapy including an anthracycline, a taxane, and trastuzumab.It is the first targeted, once-daily oral treatment option for this patientpopulation. TYKERB was granted Priority Review by the FDA in November 2006. "Tykerb is a significant breakthrough for women with advanced HER2 (ErbB2)positive breast cancer. The data clearly show that this small molecule, oral,targeted agent, in combination with capecitabine, is effective for women whosedisease has recurred despite treatment with previous therapies, includinganthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior VicePresident of the Oncology Medicine Development Centre at GSK. "The approval ofTYKERB demonstrates our R&D organisation's strong commitment to the discoveryand development of novel cancer treatments. We are dedicated to the furtherstudy and development of TYKERB in a variety of other settings includingadjuvant breast cancer as well as in other solid tumour types." This approval reflects more than 16 years of research, including more than 60clinical trials and investigator-initiated collaborative research studies.Lapatinib inhibits two validated targets in oncology, the kinase components ofEGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cellproliferation and tumour growth. As a targeted therapy, lapatinib is designed tointerfere with discrete cellular processes or disease mechanisms prevalent incancer. Lapatinib will be available in the United States within two weeks and,as an oral therapy, offers added convenience for patients. TYKERB Clinical Results This approval was based on the pivotal Phase III trial of 399 patients whichshowed that the median time to disease progression as assessed by independentreviewers was 27.1 weeks on the combination of lapatinib and capecitabine versus18.6 weeks on capecitabine alone in women with advanced or metastatic HER2(ErbB2) positive breast cancer whose disease had progressed following treatmentwith trastuzumab and other cancer therapies. The hazard ratio of 0.57 (95% CI:0.43, 0.77, p = 0.00013) represents a 43 percent reduction in the risk ofprogression for the patients on the combination arm.1 Differences betweentreatment groups based on unblinded investigator assessments were smaller butcontinued to be clinically and statistically significant. Adverse events (AEs) leading to discontinuation were similar in thelapatinib-capecitabine combination arm (14 percent) versus capecitabine alone(14 percent). Most commonly reported AEs in the lapatinib-capecitabinecombination arm included diarrhoea, hand-foot syndrome, nausea, rash, vomitingand fatigue. Left ventricular ejection fraction (LVEF), a measure of thestrength of the heart's pumping capacity, was monitored during the study. Among198 patients who received the lapatinib-capecitabine combination treatment,three experienced an asymptomatic (grade 2) decrease in LVEF and one experienceda symptomatic (grade 3) decrease in LVEF. Ongoing Trials GSK has a comprehensive clinical programme that is actively studying lapatinibin other breast cancer settings and other cancers to better identify patientpopulations that may respond to lapatinib. Marketing applications for lapatinib (TYKERB/TYVERB) have been filed around theworld, including the European Union, Switzerland, Canada, Brazil, Australia andSouth Korea. About TYKERB Lapatinib, a small molecule that is administered orally, inhibits the tyrosinekinase components of EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation ofEGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and withmultiple processes involved in tumour progression, invasion, and metastases.Overexpression of these receptors has been reported in a variety of humantumours and is associated with poor prognosis and reduced overall survival. 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. S M BicknellCompany Secretary13th March 2007 Cautionary statement regarding forward-looking statements Under the safe harbour provisions of the U.S. Private Securities LitigationReform Act of 1995, the company cautions investors that any forward-lookingstatements or projections made by the company, including those made in thisannouncement, are subject to risks and uncertainties that may cause actualresults to differ materially from those projected. Factors that may affect theGroup's operations are described under 'Risk Factors' in the Operating andFinancial Review and Prospects in the company's Annual Report on Form 20-F for2005. Notes to editors: Tykerb(R) is a registered trademark of the GlaxoSmithKline group of companies inthe United States. Tyverb(R) is a registered trademark of the GlaxoSmithKline group of companies inEurope and is the proposed trade name in certain markets, pending regulatoryapproval. Herceptin(R) is a registered trademark of Genentech, Inc. in the U.S. and RochePharmaceuticals in Europe. Xeloda(R) is a registered trademark of Roche Pharmaceuticals. To access the latest GSK Oncology media materials, visit http://www.gskcancermedia.com Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 Alice Hunt (020) 8047 5502 Gwenan White (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor enquiries: Anita Kidgell (020) 8047 5542 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. Data on file, GlaxoSmithKline, King of Prussia. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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