going
FURTHER
for breast cancer patients
for
Patients
The journey that continues to revolutionise cancer care for millions of women
1984
The Medical Research Group of Robert A. Weinberg identifies that the HER2 gene is connected with breast cancer. This discovery triggers a decades-long scientific quest to explore the many ways that the HER2 biomarker can guide personalised therapies and diagnostics that transform breast cancer care and reshape the survival curve for patients.
1990
Genentech develops Herceptin, a ground-breaking first-of-its-kind anti-HER2 monoclonal antibody to treat breast cancer by blocking the tumour-stimulating effects of HER2.
Over the past two decades, our HER2-targeted medicines have transformed the natural course of devastating HER2-positive breast cancer disease and changed the patient experience from despair to hope.
1998
FDA approves Herceptin as a personalised therapy for women with HER2-positive breast cancer.
2000
European Union approves Herceptin, expanding the reach of this life-saving drug.
FDA approves PATHWAY HER2 (CB11) IHC diagnostic test to identify women who may benefit from Herceptin.
2000
Herceptin reduces breast cancer mortality by 30% in clinical trials with over 10,000 women.
2005
FDA approves Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, the market-leading HER2 IHC assay.
2007
2011
FDA approves PERJETA, a Genentech/Roche monoclonal antibody that functions as a HER2 inhibitor therapy.
The PERJETA-Herceptin combination is standard of care, improving survival in women with high-risk, early-stage HER2-positive breast cancer, and significantly extending time to disease progression in first-line metastatic disease, transforming outcomes for patients in unprecedented ways.
2012
FDA approves KADCYLA,
a Genentech/Roche early antibody-drug conjugate therapy combining Herceptin with a chemotherapy agent – another personalised treatment option for patients with metastatic HER2-positive breast cancer.
2013
FDA approves VENTANA HER2 Dual ISH DNA Probe Cocktail with new oligo probes and improved detection chemistry, delivering all the original benefits of INFORM HER2 Dual ISH, with a more robust assay for the lab.
2020
2021
As of 2021 – 3.6 million women have been treated with Herceptin , and women with HER2-positive breast cancer now have among the highest survival rates compared with all women with breast cancer.
Deep pipeline of HER2 IVD development programs
2023
and beyond
Roche continues to investigate further into multiple new tumour indications for HER2 along with new methods of interpretation that will help bring personalised treatment options to an ever-increasing number of oncology patients.
going
into the science
FURTHER
Advancing personalised healthcare in breast cancer
We are experiencing a renaissance in HER2-targeted diagnostics, and Roche is at its center.
As precision medicine evolves, key factors are driving new innovations in HER2
Our growing understanding of cancer and of HER2 are fueling the development of more advanced strategies for detection and treatment that harness the power of this biomarker.
As personalised patient care becomes increasingly mainstream, more and more people will benefit from these innovative solutions and life-changing therapies.
Focused
on furthering
advancements
in HER2 testing
We are answering the call to ensure appropriate patient selection for the next generation of HER2-targeted therapies. Roche is working to develop companion diagnostics that will continue to play a critical role in driving increased accessibility to these personalised treatments.
We are increasing the potential for improved care for people everywhere, and we’re just getting started.
Read more
going
beyond our best
FURTHER
We do our best for who she is today … and all that she will be tomorrow
Every woman is unique –
and her case is as complex as she is.
Prognose, predict and personalise breast cancer care for every patient with our comprehensive breast diagnostic portfolio.
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody
PATHWAY/VENTANA anti-HER2 (4B5) Rabbit Monoclonal Antibody
VENTANA HER2 Dual ISH DNA Probe Cocktail
VENTANA PD-L1 (SP142) Assay
Our analytic breast assays aid in breast patient management, prognosis and prediction of therapy outcomes.
Our companion diagnostic breast assays help identify patients who will benefit from targeted therapies.
ER provides significant value as a prognostic factor, predicting response to hormone therapy and disease-specific survival.
14,15,16
Provides significant value as a prognostic factor and predicts response to hormone therapy, even in ER negative patients.
Enables confident assessment of tumour aggressiveness with intense nuclear staining and improved sensitivity and specificity.
Globally trusted for higher overall proficiency assessment scores compared to other clones, this widely adopted assay has helped identify thousands of women for treatment with highly effective personalised therapies.
Robust and highly reproducible between pathologists, our second-generation HER2 Dual ISH assay now delivers improved performance with oligo probes and new detection kits.
First and only companion test to identify patients with triple-negative breast cancer (TNBC) for immunotherapy treatment with TECENTRIQ (in countries accepting the CE Mark only).
17
18
“Medicine is not good enough.
Start there, and make it better.”
Our founder is also our inspiration for the future. Pathologist Thomas Grogan, MD, started Ventana Medical Systems, Inc. (now Roche Tissue Diagnostics) to improve the standard of care for cancer patients through faster, more personalised diagnostics.
Watch video
But we still have work to do.
For the first time, female breast cancer has surpassed lung as the most commonly diagnosed cancer worldwide.
19
Breast Cancer
Lung Cancer
We are committed to meeting this calling head-on through innovation. Our breast cancer diagnostics pipeline is a key focus of our creative energy, resources, and investment.
In 2021, we invested 24% of our total drug sales back into research and development – relentlessly pursuing the cure. We remain pharma’s biggest investor in the future of patient care.
24%
Our breast
Portfolio
Exploring new
frontiers
History of
improving lives
For
Patients
Into the
Science
Beyond our
Best
breast cancer survivor
Lisa,
See Lisa’s story
1. A Brief History of Breast Cancer; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4318603/
2. A brief history of Herceptin® and the HER2 cancer gene; https://www.breastcenter.com/2020/03/04/a-brief-history-of-herceptin-and-the-her2-cancer-gene/
3. Perceptions of Herceptin: a monoclonal antibody for the treatment of breast cancer; https://pubmed.ncbi.nlm.nih.gov/10850281/
4. European Medicines Agency statement on Herceptin; https://www.ema.europa.eu/en/news/european-medicines-agency-statement-herceptin
5. HER2 testing: Current status and future directions; https://www.sciencedirect.com/science/article/pii/S0305737213001904
6. Use of trastuzumab for the treatment of early stage breast cancer; https://pubmed.ncbi.nlm.nih.gov/16925482/
7. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990081S003
8. New Automated HER2 Test Promises Faster, More Accurate Testing; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278128/
9. First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer; https://pubmed.ncbi.nlm.nih.gov/23801166/#
10. Kadcyla FDA Approval History; https://www.drugs.com/history/kadcyla.html
11. VENTANA HER2 Dual ISH DNA Probe Cocktail; https://www.fda.gov/medical-devices/recently-approved-devices/ventana-her2-dual-ish-dna-probe-cocktail-p190031
12. Herceptin has saved countless women’s lives and earned UCLA’s Dr. Dennis Slamon the Lasker Award;
https://www.uclahealth.org/physiciansupdate/herceptin-has-saved-countless-women-s-lives-and-earned-ucla-s-dr-dennis-slamon-the-lasker-award
13. Herceptin PBRER 2021, data on file. Based on the sales of Herceptin and recalculated patient number of exposure to Herceptin.
14. CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbi Monoclonal Primary Antibody (package insert). Tucson, AZ: VENTANA Medical Systems, Inc. 2008.
15. Welsh A. et al. Quantitative Analysis of Estrogen Receptor Expression Shows SP1 Antibody of More Sensitive Than 1D5. Apple Immunohistochem Mol Morphol. 2013;21(2):139-147
16. Yamamoto-Ibusuki M, Yamamoto Y, Yamamoto S, et al. Comparison of prognostic value between combined immunohistochemical score of estrogen receptor, human epidermal growth
17. Liu, S, Cchia SK, Mehl, E, et al. Breast Cancer Res Treat. Progesterone receptor is a significant factor associated with clinical outcomes and effect of adjuvant tamoxifen therapy in breast cancer patients
18. Based on 5 years of data from a leading external quality assessment scheme. Retrieved from http://www.nordiqc.org/epitopes.htm
19. Cancer.org; Cancer Facts & Figures 2020; 2. https://pubmed.ncbi.nlm.nih.gov/33538338/
20. https://www.evaluate.com/vantage/articles/data-insights/other-data/roche-remains-big-pharmas-biggest-rd-spender
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References:
in-situ
Roche launches the new INFORM HER2 Dual
ISH DNA Probe Cocktail – delivering fully automated, overnight ISH ( hybridization) results that can be reviewed on a standard microscope without the need for a
darkroom – so patients receive answers sooner.
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