FDA approval of Tykerb

GlaxoSmithKline PLC
13 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 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 tumours 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 recurred despite treatment with previous therapies, including
anthracyclines, taxanes and trastuzumab," said Paolo Paoletti, MD, Senior Vice
President of the Oncology Medicine Development Centre at GSK. "The approval of
TYKERB demonstrates our R&D organisation'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 other settings including
adjuvant breast cancer as well as in other solid tumour types."

This approval reflects more than 16 years of research, including more than 60
clinical trials and investigator-initiated collaborative research studies.
Lapatinib inhibits two validated targets in oncology, the kinase components of
EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell
proliferation and tumour growth. As a targeted therapy, lapatinib is designed to
interfere with discrete cellular processes or disease mechanisms prevalent in
cancer.  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 which
showed that the median time to disease progression as assessed by independent
reviewers was 27.1 weeks on the combination of lapatinib 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
lapatinib-capecitabine combination arm (14 percent) versus capecitabine alone
(14 percent). Most commonly reported AEs in the lapatinib-capecitabine
combination arm included diarrhoea, 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 lapatinib-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 programme that is actively studying lapatinib
in other breast cancer settings and other cancers to better identify patient
populations that may respond to lapatinib.

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

Lapatinib, a small molecule that is administered orally, inhibits the tyrosine
kinase components of EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of
EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with
multiple processes involved in tumour progression, invasion, and metastases.
Overexpression of these receptors has been reported in a variety of human
tumours 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.


S M Bicknell
Company Secretary
13th March 2007


Cautionary statement regarding forward-looking statements

Under the safe harbour 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 
http://www.gskcancermedia.com


Enquiries:
                                        
UK Media enquiries:                     Philip Thomson          [phone]
                                        Alice Hunt              [phone]
                                        Gwenan White            [phone]

US Media enquiries:                     Nancy Pekarek           [phone]
                                        Mary Anne Rhyne         [phone]
                                        Patricia Seif           (215)  751 7709

European Analyst/Investor enquiries:    Anita Kidgell           [phone]
                                        David Mawdsley          [phone]
                                        Sally Ferguson          [phone]

US Analyst/ Investor enquiries:         Frank Murdolo           [phone]
                                        Tom Curry               [phone]


References

     
1.   Data on file, GlaxoSmithKline, King of Prussia.


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