GREAT news for Her2+ metastatic women!

Finally Health Canada has approved the use of Tykerb (Lapatinib) for use in Canada to treat women with her2+ metastatic breast cancer who no longer respond to Herceptin! The announcement was made on May 26th & I’ve been waiting for this for a long time. I first heard about this drug about 3 years ago at a conference for young women with breast cancer. The following year it was approved by the FDA for use in the U.S. (that was March of 2007). I’m not saying that you could NOT get Tykerb here in Canada….but you had to be part of a clinical trial to get it. That can be pretty hard to hear the word “no, you can’t get this” when you know you’re losing your cancer battle. I wonder if my friend Joanne would have benefitted from Tykerb had it been available to her last fall? She lost her battle with breast cancer in September of 2008. The Herceptin was no longer working for her, the cancer was just too smart. She couldn’t get or try Tykerb because it was only in clinical trials, and the trial was full. (Mind you, you have to reach fairly strict requirements to make it into a clinical trial. They may turn you down because they don’t like the location of one of your metastases.)

So, the Herceptin is still working for me and I am SO very thankful for that, but it’s been almost 9 years and I wonder if my cancer is going to get the upper hand sometime soon. How come it’s worked for me for so long and it hasn’t for others? I ask myself that all the time and there’s no answer…it just happens. I’m still living a life surrounded by questions and the dread of hearing the words “your cancer is spreading”. Now I have so much more hope because Tykerb has been approved! IF my cancer happens to outsmart the Herceptin perhaps I’ll be able to get Tykerb and maybe that will work for me. Another great thing about Tykerb is that it CAN cross the blood-brain barrier (from what I understand). Herceptin is too “large” and can not get into the brain, but I’ve heard that Tykerb can which is GREAT news for those with brain mets.

Here’s the official release if you’d like to read it:

TYKERB(TM) is the first oral, once-a-day HER2 targeted therapy approved by Health Canada

 

     MISSISSAUGA, ON, May 26 /CNW/ - Women living with HER2 positive breast

cancer now have a new treatment option for the first time in almost ten years.

Health Canada has approved Tykerb(TM) (lapatinib ditosylate) tablets for use

in combination with an oral chemotherapy, capecitabine (Xeloda(R)), for the

treatment of patients with advanced or metastatic breast cancer whose tumours

overexpress HER2 (ErbB2) and who have progressed following prior therapies

including taxanes, anthracyclines and trastuzumab (Herceptin(R)). HER2

positive breast cancer is an aggressive form of the disease that affects

approximately 20 per cent of breast cancer patients.(1)

    

“Today marks an important milestone,” said Dr. Kathleen Pritchard, Senior

Scientist at Sunnybrook Odette Cancer Centre, and Professor of Medicine at the

University of Toronto. “Tykerb is a new way to treat HER2 positive breast

cancer that gives women with advanced HER2 positive breast cancer another

weapon in the fight to control their disease, where before they had no other

options.”

    

Tykerb(TM) slows the progression of advanced breast cancer in patients

whose disease has progressed following treatment with other cancer therapies.

Women with HER2 (ErbB2) positive breast cancer are at a greater risk of

disease progression and death compared to women with tumours that do not

overexpress this protein.(2)

    

Tykerb(TM) has a novel mechanism of action that is different from current

licensed targeted therapies for HER2 positive disease. It is a small molecule

that is administered orally and works by getting inside the cancer cell and

inhibiting the EGFR (ErbB1) and HER2 (ErbB2) receptors, which are involved in

the growth and proliferation of some cancers.

    

“In 2004, when my breast cancer came back, my doctor said I was out of

treatment options,” says Cecile Comeau, a Canadian HER2 positive breast cancer

patient. “He then suggested I join a clinical trial for a new oral therapy, I

had nothing to lose. That decision has meant everything to me, and to my

family.”

    

“Tykerb’s approval means a new option in our arsenal in the fight against

HER2 positive breast cancer and we look forward to the day when it is made

available to Canadian women in every province,” says Diana Ermel, President,

Canadian Breast Cancer Network. “Dedication to research and new therapies like

this one provides women with more tools they need to fight their disease.”

    

“The approval of Tykerb is very important for women with HER2 positive

breast cancer - both now and in the future,” says Virginia Yule, Executive

Director, Willow Breast Cancer Support Canada. “When new treatments become

available, they provide more options for physicians and women to deal with

their breast cancer.”

 

     About Breast Cancer

         -  In 2009, an estimated 22,700 Canadian women will be diagnosed with

            breast cancer.(3)

         -  For Canadian women, breast cancer is the second leading cause of

            cancer mortality.(4)

         -  Breast cancer is the most common cancer and cause of cancer death

            in women aged 20 - 59, accounting for 37 per cent of new cases and

            22 per cent of deaths.(5)

         -  One in nine women is expected to develop breast cancer during her

            lifetime. One in 28 will die of it.(6)

         -  HER2 (otherwise known as ErbB2) positive breast cancer is an

            aggressive form of cancer that hits women in their prime.

            Approximately 20 per cent of women with breast cancer overexpress

            the HER2 (ErbB2) protein.(7) Since it is a particularly aggressive

            form of cancer, women with HER2 (ErbB2) positive breast cancer are

            at a greater risk of disease progression and death compared to

            women with breast cancer tumors that do not overexpress HER2

            (ErbB2).(8) The five-year relative survival rate is significantly

            lower among women with a more advanced stage (stage III or IV) of

            cancer at diagnosis at 59% and 26% respectively.(9)

         -  GSK has a comprehensive clinical trial program that is actively

            studying Tykerb(TM) tablets in other breast cancer settings and

            other cancers to better identify patient populations that may

            respond to therapy. These include the earlier stages of HER2

            (ErbB2) positive breast cancer,(10),(11),(12) inflammatory breast

            cancer,(13) brain metastases,(14) as well as head and neck, and

            gastric cancers.(15),(16)

 

     Clinical Trials

     The approval was based on a pivotal phase III trial (EGF100151) in which

women with locally advanced or metastatic HER2 positive breast cancer whose

disease had progressed following prior treatment with anthracyclines, taxanes

and trastuzumab were given either the combination of Tykerb(TM) and

capecitabine, or capecitabine alone. Tykerb(TM) in combination with

capecitabine was shown to increase the median time to progression compared to

capecitabine alone. There was a consistent benefit in time to progression

(TTP) by both unblinded investigator and blinded independent assessment,

although the magnitude of TTP by independent assessment was likely

overestimated.

         -  By investigator assessment, median TTP was increased from 18.3

            weeks to 23.9 weeks when taken in combination with capecitabine

            versus capecitabine alone.

         -  By independent assessment, median TTP was increased from 18.6

            weeks to 27.1 weeks in the Tykerb(TM) with capecitabine compared

            to the capecitabine alone.

     In Canada more than 50 investigators have been involved in Tykerb(TM)

breast cancer clinical trials to date involving over 290 patients in nine

provinces.

 

     The most common adverse events during therapy with Tykerb(TM) plus

capecitabine were gastrointestinal (diarrhea, nausea and vomiting), skin

toxicities (hand foot syndrome and rash) and fatigue. The majority of adverse

events and laboratory abnormalities were mild to moderate in severity. The

most common grade 3 and 4 adverse reactions were diarrhea and hand foot

syndrome. Tykerb(TM) has also been associated with cardiac toxicity, pulmonary

toxicity and hepatotoxicity.(17)

 

               About GlaxoSmithKline Inc.

     GlaxoSmithKline Inc. - one of the world’s leading research-based

pharmaceutical, vaccine and healthcare companies - is committed to improving

the quality of human life by enabling people to do more, feel better and live

longer. In Canada, GlaxoSmithKline is a top 15 investor in research and

development, contributing more than $156 million in 2008 alone. GSK is

designated a Caring Company by Imagine Canada, and is consistently recognized

as one of the 50 best companies to work for in Canada. For company information

please visit, www.gsk.ca.

 

     References

     ————————————————————————-

     (1)  Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and

          breast cancer : ten years of targeted anti-HER-2 therapy and

          personalized medicine. The Oncologist 2009;14:320-368.

     (2)  Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human

          breast cancer: correlation of relapse and survival with

          amplification of the HER-2/neu oncogene. Science 1987:235:177-87.

     (3)  Canadian Cancer Society’s Steering Committee: Canadian Cancer

          Statistics 2009. Toronto: Canadian Cancer Society, 2009.

     (4)  Ibid.

     (5)  Ibid.

     (6)  Ibid.

     (7)  Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and

          breast cancer: ten years of targeted anti-HER-2 therapy and

          personalized medicine. The Oncologist 2009;14:320-368.

     (8)  Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human

          breast cancer: correlation of relapse and survival with

          amplification of the HER-2/neu oncogene. Science 1987:235:177-87.

     (9)  Canadian Cancer Statistics 2007. Canadian Cancer Society. Page 84.

     (10) Moy B, et al. Phase III study of lapatinib after completion of

          adjuvant chemotherapy in trastuzumab-naïve women with ErbB2-

          overexpressing breast cancer: TEACH Study. Poster presentation, 10th

          International Conference on Primary Therapy of Early Breast Cancer

          in St Gallen, Switzerland. Thursday 17th March 2007.

     (11) Piccart M. et al. A Phase III Study for HER2-Overexpressing Early

          Breast Cancer: ALTTO Study. Poster presentation, 10th International

          Conference on Primary Therapy of Early Breast Cancer in St Gallen,

          Switzerland. Thursday 17th March 2007.

     (12) Baselga J. et al. A Phase III Translational Study for HER2-

          Overexpressing Early Breast Cancer: Neo-ALTTO Study. Poster

          presentation, 10th International Conference on Primary Therapy of

          Early Breast Cancer in St Gallen, Switzerland. Thursday 17th March

          2007.

     (13) Kaufman B, Trudeau M, Awada A, et al. Lapatinib monotherapy in

          patients with Her2-overexpressing relapsed or refractory

          inflammatory breast cancer: final results and survival of the

          expanded HER2+ cohort in EGF103009, a phase II study. The Lancet

          Oncology. Published online April 27, 2009. DOI:10.1016/S1470-2045

          (09)70087-7.

     (14) Lin NU, Dieras V, Paul D, et al. Multicenter phase II study of

          lapatinib in patients with brain metastases from HER2-positive

          breast cancer. Clin Cancer Res 2009;15(4):1452-1459.

     (15) El-Hariry, I., Harrington K. et al. A phase I, open label study

          (EGF100262) of lapatinib plus chemoradiation in patients with

          locally advanced squamous cell carcinoma of the head and neck

          (SCCHN). Oral presentation, 1st International Meeting on Innovative

          Approaches in Head & Neck Oncology, Barcelona, Spain. 22nd - 24th

          February 2007.

     (16) Ravaud A, Gardner, R. Hawkins H et al. Efficacy of lapatinib in

          patients with high tumor EGFR expression: Results of a phase III

          trial in advanced renal cell carcinoma (RCC). Journal of Clinical

          Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24,

          No. 18S (June 20 Supplement) 2006: 4502

     (17) Product Monograph of Tykerb(TM) (lapatinib ditosylate) tablets,

          GlaxoSmithKline Inc., May 2009.

 

For further information: Jilda Lazer, Environics Communications Inc., (416)

969-2737, jlazer@environicspr.com; Corporate Communications,

GlaxoSmithKline Inc., (905) 819-3363