Herceptin Approved for Early Breast Cancer in NZ

News Release

Herceptin (trastuzumab) Approved for Early Breast Cancer in New Zealand
Roche to focus on completing funding processes.

Auckland, 23rd March 2006 – Roche Products (New Zealand) Limited is pleased to confirm it has received regulatory approval for the use of Herceptin in HER2 positive early breast cancer.

New Zealand is the first country in the world to achieve formal regulatory approval.

The new licensed indication approved by Medsafe (The New Zealand Medicines and Medical Devices Safety Authority), permits the use of Herceptin for the treatment of HER2 positive early breast cancer in women following surgery and completion of adjuvant chemotherapy, provided they have normal heart function. Treatment with Herceptin is for one year.

The approval is based on the results of the international HERA (HERceptin Adjuvant) study. HERA is one of the largest breast cancer trials ever conducted, with more than 5,000 women in 39 countries (including New Zealand) participating. The study showed that the administration of Herceptin following standard chemotherapy significantly reduced the risk of disease recurrence for women with early-stage HER2-positive breast cancer by 46%1.

Until today, Herceptin was only approved for use in women with advanced HER2 positive breast cancer, a particularly aggressive and frequently recurring breast cancer that affects between 20-30% of all breast cancer patients2. Women diagnosed with breast cancer are tested to identify their HER2 status in advance of treatment, to ensure Herceptin is only used for women most likely to benefit.

“Todays announcement represents a major step forward in our quest to ensure New Zealand women get rapid and appropriate access to this significant advance in breast cancer treatment. Our focus will now turn to completing the necessary reimbursement processes with PHARMAC to ensure Herceptin is funded as soon as possible.” said Mr Svend Petersen, Managing Director, Roche New Zealand.

“Roche is confident Herceptin can meet PHARMAC’s clinical and cost-effectiveness requirements and that it provides value. It is a justifiable investment that will benefit the women of New Zealand who have HER2 positive early breast cancer.” said Mr Petersen.

ENDS

References
1) Piccart-Gebhart, MJ, Proctor M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER-2 positive breast cancer. N Engl J Med 2005;353(16):1659-72
2) Harries M, Smith I. The development and clinical use of Trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002

What you should know about Herceptin:
Herceptin (trastuzumab) is a Prescription Medicine used to treat patients with early breast cancer and metastatic (spreading) breast cancer who have tumours with a large amount of the HER2 protein.
Tell your doctor if you have coronary artery disease, high blood pressure, heart failure, lung tumours or disease, or if you are pregnant or breastfeeding.

Possible unwanted effects: Common: chills, shivering, fever, nausea, vomiting, pain, stiffness, shaking, headache, dizziness, cough, skin rash, itchy skin, weakness, fatigue, abnormal or fast heart beat, insomnia, anxiety, depression, runny or blocked nose, cold/flu-like symptoms, chest infection, worsening cough, pain on urination, diarrhoea, hair loss, muscle or joint soreness. Serious: shortness of breath or breathing difficulty, severe cough, severe swelling of feet or legs, chest pain, abnormal heart beat, severe diarrhoea, feeling faint.

Ask your oncologist if Herceptin is right for you. Use strictly as directed. If symptoms continue or if you experience side effects or would like further information, please talk to your oncologist or visit www.medsafe.govt.nz for Herceptin Consumer Medicine Information. Herceptin (150mg and 440mg vials) is a funded medicine under Section H of the Pharmaceutical Schedule for patients who meet pre-defined criteria. Herceptin is not funded for the treatment of early breast cancer. A prescription charge and normal oncologist fees may apply.

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