TYKERB (lapatinib ditosylate) - Updated Information on Efficacy - For the Public

Starting date:

March 25, 2013

Posting date:

March 25, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-26287

This is duplicated text of a letter from GlaxoSmithKline Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Information on TYKERB (lapatinib ditosylate)

March 25, 2013

Subject: Updated Information – TYKERB^® (lapatinib ditosylate)-based treatments are less effective than HERCEPTIN^® (trastuzumab)-based treatments in certain settings

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 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 or on the Health Canada website. 

For media inquiries, please contact GlaxoSmithKline Communications at (905) 819-3363.

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 side effect 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
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

Dr. Glenn Crater,
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Inc.

References:

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