Public Communication - Health Canada Endorsed Important Information on TYKERB® (lapatinib ditosylate)

Public Communication - Health Canada Endorsed Important Information on 
TYKERB® (lapatinib ditosylate) 
Subject: Updated Information - TYKERB(®) (lapatinib ditosylate)-based 
treatments are less effective than HERCEPTIN(® )(trastuzumab)-based 
treatments in certain settings 
MISSISSAUGA, ON, March 25, 2013 /CNW/ - GlaxoSmithKline Inc., in consultation 
with Health Canada, is providing Canadians with updated information on the use 
of the cancer treatment drug, TYKERB(®). For breast cancer patients with 
metastatic breast cancer that is HER 2 positive, two recent studies have shown 
that use of TYKERB(®) in combination with chemotherapy is less effective than 
the use of HERCEPTIN(®) in combination with chemotherapy. 
Based on the analyses of data from these two studies, GlaxoSmithKline would 
like to advise you of the following: 
|    --  In patients with metastatic breast cancer that is HER-2      |
|        positive, therapy with HERCEPTIN(®) should be considered a   |
|        more effective initial treatment than therapy with TYKERB(®).|
|                                                                     |
|    --  If you are taking TYKERB(®) and have any questions regarding |
|        how this new information may affect your treatment, contact  |
GSK has sent a letter to healthcare professionals detailing the results of 
these two new studies. Furthermore, physicians have been informed that 
TYKERB(®)-based therapies should not be prescribed unless their patients' 
metastatic breast cancer has progressed during treatment with 
HERCEPTIN(®)-based therapies. 
Further information may be obtained on the Canadian website of GlaxoSmithKline 
( or on the Health Canada website. 
Managing marketed health product-related side effects depends on health care 
professionals and consumers reporting them. Reporting rates determined on the 
basis of spontaneously reported post-marketing side effects are generally 
presumed to underestimate the risks associated with health product treatments. 
Any serious or unexpected side effects in patients receiving TYKERB(®) should 
be reported to GlaxoSmithKline Inc. or Health Canada. 
|GlaxoSmithKline Inc.                                                                                                    
|7333 Mississauga Road                                                                                                   
|Mississauga, Ontario                                                                                                    
|L5N 6L4                                                                                                                 
|Phone:  1-800-387-7374                                                                                                  
|You can report any suspected adverse reactions associated with the use of health products to Health Canada by:          
|    --  Calling toll-free at 1-866-234-2345; or                                                                         
|    --  Visiting MedEffect Canada's Web page on Adverse Reaction Reporting      |
|        (|
|        for information on how to                                                                                       
|        report online, by mail or by fax                                                                                
|For other health product inquiries related to this communication, please contact Health Canada at:                      
|Marketed Health Products Directorate                                                                                    
|Telephone: 613-954-6522                                                                                                 
|Fax: 613-952-7738                                                                                                       
Original signed by 
Dr. Glenn Crater,
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Inc. 
Gelmon KA, Boyle F, Kaufman B, et al. Open-label phase III randomized 
controlled trial comparing taxane-based chemotherapy (Tax) with lapatinib (L) 
or trastuzumab (T) as first-line therapy for women with HER2+ metastatic 
breast cancer: Interim analysis (IA) of NCIC CTG MA.31/GSK EGF 108919. J Clin 
Oncol. 2012;30(suppl; abstr LBA671). 
X Pivot, V Semiglazov, B Zurawsky, R Allerton, A Fabi, E Ciruelos, R Parikh, M 
DeSilvio, S Santillana and R Swaby : [CEREBEL (EGF111438): An open label 
randomized phase III study comparing the incidence of CNS metastases in 
patients(pts) with HER2+ Metastatic Breast Cancer (MBC), treated with 
Lapatinib plus Capecitabine (LC) versus Trastuzumab plus Capecitabine (TC). 
Ann Oncol (2012) 23(suppl 9): ixe5 abstract LBA11 doi:10.1093/annonc/mds499 
For media inquiries, please contact GlaxoSmithKline Communications at  (905) 
SOURCE: GlaxoSmithKline Inc. 
To view this news release in HTML formatting, please use the following URL: 
CO: GlaxoSmithKline Inc.
ST: Ontario
-0- Mar/25/2013 13:00 GMT