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
If you are taking TYKERB® and have any questions regarding how this new information may affect
your treatment, contact your doctor.
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 (www.gsk.ca) 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.
7333 Mississauga Road
You can report any suspected adverse reactions associated with the use
of health products to Health Canada by:
For other health product inquiries related to this communication, please
contact Health Canada at:
Marketed Health Products Directorate
Original signed by
Dr. Glenn Crater,
Vice President, Medical and Chief Medical Officer
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
SOURCE: GlaxoSmithKline Inc.
For further information:
For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.