FDA Approves TYKERB(R) (lapatinib) in Combination With Xeloda(R) (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy

GlaxoSmithKline's New Breast Cancer Drug May Give Women More Options

    PHILADELPHIA, March 13 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc
 ( GSK) (LSE: GSK) announced today that the United States Food and Drug
 Administration (FDA) approved TYKERB(R) (lapatinib), in combination with
 Xeloda(R) (capecitabine), for the treatment of patients with advanced or
 metastatic breast cancer whose tumors overexpress HER2 and who have
 received prior therapy including an anthracycline, a taxane, and
 trastuzumab. It is the first targeted, once-daily oral treatment option for
 this patient population. 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 whose disease has progressed on previous therapies,
 including anthracyclines, taxanes and trastuzumab," said Paolo Paoletti,
 MD, Senior Vice President of the Oncology Medicine Development Center at
 GSK. "The approval of TYKERB demonstrates our R&D organization's strong
 commitment to the discovery and development of novel cancer treatments. We
 are dedicated to the further study and development of Tykerb in a variety
 of settings including adjuvant breast cancer as well as in other solid
 tumor types."
     This approval reflects more than 16 years of research, including more
 than 60 clinical trials and investigator-initiated collaborative research
 studies. TYKERB inhibits two validated targets in oncology, the kinase
 components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly
 associated with cancer cell proliferation and tumor growth. As a targeted
 therapy, TYKERB is designed to interfere with discrete cellular processes
 or disease mechanisms prevalent in cancer. TYKERB will be available in the
 United States within two weeks and, as an oral therapy, offers added
 convenience for patients.
     "The approval of TYKERB is an important milestone in our commitment to
 become a major oncology company that focuses on scientific innovation and
 genuine patient needs," said Chris Viehbacher, President, US
 Pharmaceuticals at GSK. "Our rich pipeline of oncology medicines
 underscores our commitment to cancer patients. This commitment extends to
 programs to help ensure that women who may benefit from TYKERB will have
 access to it."
     TYKERB Patient Support
     To support patient access, GSK has established a single source for
 information and support called Tykerb(R) CARES. Through this comprehensive
 program, knowledgeable consultants are available to answer product-related
 questions from patients and physicians, and can assist them with obtaining
 TYKERB. Additionally, Tykerb(R) CARES reimbursement counselors will help
 patients understand their insurance coverage and, if appropriate, assist in
 identifying alternative financial support. More information regarding
 Tykerb(R) CARES can be found by calling 1-866-4-TYKERB (89-5372). Program
 hours are Monday -- Friday, 8:30 am - 8:00 pm ET.
     TYKERB Clinical Results
     This approval was based on the pivotal Phase III trial of 399 patients
 which showed that the median time to disease progression as assessed by
 independent reviewers was 27.1 weeks on the combination of TYKERB and
 capecitabine versus 18.6 weeks on capecitabine alone in women with advanced
 or metastatic HER2 (ErbB2) positive breast cancer whose disease had
 progressed following treatment with 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 of progression for the patients on the
 combination arm.1 Differences between treatment groups based on unblinded
 investigator assessments were smaller but continued to be clinically and
 statistically significant.
     Adverse events (AEs) leading to discontinuation were similar in the
 TYKERB-capecitabine combination arm (14 percent) versus capecitabine alone
 (14 percent). Most commonly reported AEs in the TYKERB-capecitabine
 combination arm included diarrhea, hand-foot syndrome, nausea, rash,
 vomiting and fatigue. Left ventricular ejection fraction (LVEF), a measure
 of the strength of the heart's pumping capacity, was monitored during the
 study. Among 198 patients who received the TYKERB-capecitabine combination
 treatment, three experienced an asymptomatic (grade 2) decrease in LVEF and
 one experienced a symptomatic (grade 3) decrease in LVEF.
     Ongoing Trials
     GSK has a comprehensive clinical program that is actively studying
 TYKERB in other breast cancer settings and other cancers to better identify
 patient populations that may respond to TYKERB.
     Marketing applications for lapatinib (TYKERB/TYVERB) have been filed
 around the world, including the European Union, Switzerland, Canada,
 Brazil, Australia, and South Korea.
     About Tykerb
     TYKERB, a small molecule that is administered orally, inhibits the
 tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors.
 Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell
 proliferation and with multiple processes involved in tumor progression,
 invasion, and metastases. Overexpression of these receptors has been
 reported in a variety of human tumors and is associated with poor prognosis
 and reduced overall survival.
     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. Cautionary statement regarding forward-looking
 statements
     Under the safe harbor provisions of the U.S. Private Securities
 Litigation Reform Act of 1995, the company cautions investors that any
 forward-looking statements or projections made by the company, including
 those made in this announcement, are subject to risks and uncertainties
 that may cause actual results to differ materially from those projected.
 Factors that may affect the Group's operations are described under 'Risk
 Factors' in the Operating and Financial Review and Prospects in the
 company's Annual Report on Form 20-F for 2005.
     Notes to editors:
     TYKERB(R) is a registered trademark of the GlaxoSmithKline group of
 companies in the United States.
     TYVERB(R) is a registered trademark of the GlaxoSmithKline group of
 companies in Europe and is the proposed trade name in certain markets,
 pending regulatory approval.
     Herceptin(R) is a registered trademark of Genentech, Inc. in the U.S.
 and Roche Pharmaceuticals in Europe.
     Xeloda(R) is a registered trademark of Roche Pharmaceuticals.
     To access the latest GSK Oncology media materials, visit
 https://www.gsk/media.com or http://www.gskcancermedia.com
     Inquiries:
 
 
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                                      Mary Anne Rhyne    +1 919 483 2839
 
 
     UK Media inquiries:              Philip Thomson     +44 20 8047 5502
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     European Analyst/Investor        Anita Kidgell      +44 20 8047 5542
     inquiries:
                                      Sally Ferguson     +44 20 8047 5543
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     US Analyst/ Investor             Frank Murdolo      +1 215 751 7002
     inquiries:
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     References
     (1) Data on file, GlaxoSmithKline, King of Prussia.
 
 

SOURCE GlaxoSmithKline plc