Herceptin Receives Positive Opinion in Europe for Early Use in HER2-Positive Breast Cancer

Basel, Switzerland (ots/PRNewswire) -

- Important Step Towards Broad Access of Herceptin for Women WithAggressive Form of Breast Cancer

Roche today announced that the European Union's Committee forHuman Medicinal Products (CHMP) has issued a positive recommendationfor the use of Herceptin following surgery and standard chemotherapyas adjuvant treatment of early-stage HER2-positive breast cancer.HER2-positive breast cancer, which affects approximately 20% -30%[i] of women with breast cancer, demands special and immediateattention because the tumours are fast-growing and there is a higherlikelihood of relapse.

The CHMP's decision is based on impressive results from theinternational HERA (HERceptin Adjuvant) study which showed Herceptinfollowing standard chemotherapy significantly reduces the risk ofcancer coming back by 46% compared to chemotherapy alone. [ii] Theseremarkable benefits have also been seen in three other major globaland US studies.[iii]

"The results from four large-scale trials speak for themselves:Herceptin consistently reduces the risk of relapse when used in earlystages, providing the best chance of long-term survival to women withan extremely aggressive form of breast cancer," commented EdHoldener, Head of Roche's Global Pharma Development. "The CHMP'stimely decision represents a significant milestone, bringing patientsand the medical community one step closer to broadly accessing thiseffective therapy in the EU."

The positive opinion will now be proposed for approval by theEuropean Commission. Herceptin is the only approved therapyspecifically for the treatment of metastatic (advanced) HER2-positivedisease, so the new approval will allow Herceptin to be usedfollowing surgery for early-stage breast cancer, as `adjuvant'therapy.

In the US, Genentech filed a supplemental Biologic LicenseApplication (sBLA) for the use of Herceptin in early-stageHER2-positive breast cancer with the Food and Drug Administration(FDA) on February 15th, 2006. The application is based on data fromthe combined interim analysis of two large US trials,[iv] andGenentech has received a priority review designation.

About the HERA study

HERA, conducted by the Roche and Breast International Group(BIG),[v] is one of the largest adjuvant studies ever carried outamong breast cancer patients; enrolment to the trial began inDecember 2001, and nearly 5,100 HER2-positive patients were enrolledat 480 sites in 39 countries across the world. HERA is a randomisedtrial, which, following standard adjuvant systemic chemotherapy andradiotherapy (if applicable), evaluates observation versus Herceptinevery three weeks for 12 months or 24 months in women withearly-stage HER2-positive breast cancer. The HERA study allowed forthe use of a wide range of chemotherapy regimens, and both lymphnode-positive and lymph node-negative patients were eligible forentry into the trial.

According to the interim analysis, the primary efficacy endpointwas met, showing that in the 12-month arm, patients who receivedHerceptin had a statistically significant improvement in disease-freesurvival (the length of time after treatment during which no diseaseis found). At a median follow-up of one year, the secondary endpointof overall survival had not reached statistical significance, butshowed a clear trend towards an improvement in overall survival,which is to be confirmed as the data mature.

The interim analysis compared Herceptin versus observation and didnot include a comparison of 12 months versus 24 months treatmentduration. The trial will continue to assess this comparison and datawill become available in due time as the study matures.

The HERA study has an external Independent Data MonitoringCommittee (IDMC) that regularly reviews safety data. No safetyconcerns were raised by the IDMC, and the incidence of congestiveheart failure was very low (0.5% in the Herceptin arms vs. 0% in theobservation arm). Patients in this study will continue to be followedfor any side effects.

About breast cancer and Herceptin

Eight to nine percent of women will develop breast cancer duringtheir lifetime, making it one of the most common types of cancer inwomen.[vi] Each year more than one million new cases of breast cancerare diagnosed worldwide, with a death rate of nearly 400,000 peopleper year.

In HER2-positive breast cancer, increased quantities of the HER2protein are present on the surface of the tumour cells. This is knownas `HER2 positivity.' High levels of HER2 are present in aparticularly aggressive form of the disease which responds poorly tochemotherapy. Research shows that HER2-positivity affectsapproximately 20-30% of women with breast cancer.

Herceptin is a humanised antibody, designed to target and blockthe function of HER2, a protein produced by a specific gene withcancer-causing potential. In addition to its efficacy in theearly-stage breast cancer setting, Herceptin also has demonstratedimproved survival in the advanced (metastatic) setting, where itsaddition to chemotherapy allows patients to live up to one-thirdlonger than chemotherapy alone.[vii]

Herceptin received approval in the European Union in 2000 for usein patients with metastatic breast cancer, whose tumours overexpressthe HER2 protein. In addition to being indicated for use incombination with docetaxel as a first-line therapy in HER2-positivepatients who have not received chemotherapy for their metastaticdisease, it is also indicated as a first-line therapy in combinationwith paclitaxel where anthracyclines are unsuitable, and as a singleagent in third-line therapy. Herceptin is marketed in the UnitedStates by Genentech, in Japan by Chugai and internationally by Roche.Since 1998, Herceptin has been used to treat over 230,000HER2-positive breast cancer patients worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2005sales by the Pharmaceuticals Division totalled 27.3 billion Swissfrancs, and the Diagnostics Division posted sales of 8.2 billionSwiss francs. Roche employs roughly 70,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).

All trademarks used or mentioned in this release are legallyprotected.

Additional information:

- About Genentech: www.gene.com

- Roche in Oncology:www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk on cancer: www.health-kiosk.ch/start_krebs

To access video clips, in broadcast standard, free of charge,please go to: www.thenewsmarket.com.


[i] Harries M, Smith I. The development and clinical use oftrastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

[ii] Piccart-Gebhart M, Procter M, Leyland-Jones B, et al. ARandomized Trial of Trastuzumab Following Adjuvant Chemotherapy inWomen with HER2 Positive Breast Cancer. New England Journal ofMedicine 353:16 2005.

[iii] NCCTG N9831 (US), NSABP B-31 (US), BCIRG 006 (international)

[iv] Romond, E., Perez, E. et al. Trastuzumab plus AdjuvantChemotherapy for Operable HER2 Positive Breast Cancer. New EnglandJournal of Medicine 353:16 2005.

[v] Collaborative partners for the HERA study include: Roche, BIGand its affiliated collaborative groups, plus non-affiliatedcollaborative groups, and independent sites.

[vi] World Health Organization, 2000.

[vii] Extra JM, Cognetti F, Maraninchi D et al. Long-term survivaldemonstrated with trastuzumab plus docetaxel: 24-month data from arandomised trial (M77001) in HER2-positive metastatic breast cancer.Abstract #555, American Society for Clinical Oncology (ASCO) AnnualMeeting 2005.

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:Roche Group Media Office: Phone: +41-61-688-8888 / e-mail: basel.mediaoffice@roche.com, Baschi Dürr, Alexander Klauser, Daniel Piller (Head of Roche Group Media Office), Katja Prowald (Head of R&DCommunications), Martina Rupp

Roche Pharmaceuticals

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Herceptin Receives Positive Opinion in Europe for Early Use in HER2-Positive Breast Cancer