Herceptin approved for HER2-positive early breast cancer

The approval by the local regulatory authority means that South African women with all stages of this highly aggressive form of early breast cancer now have access to this life-extending treatment option. 1

According to Dr. Singh, Head of Medical at Roche Products (Pty) Ltd in Johannesburg the impressive results from the international HERA (HERceptin Adjuvant) study showed that treatment with Herceptin®, following standard chemotherapy, significantly reduces the risk of HER2-positive breast cancer coming back by approximately 50% compared to chemotherapy alone.

Similarly, remarkable benefits have also been seen in three other major global and US studies. 3,4

The strength of results from the four large trials with over 12 000 patients enrolled has also encouraged food and drug administrations around the world to act urgently to ensure access to Herceptin® for early-stage HER2-positive breast cancer patients.4 Herceptin® has already been granted approval status in various countries, and over the past two years, several other countries have developed clinical guidelines and committed funding to allow eligible patients faster access, prior to license. South Africa was amongst these. Since 1998, Herceptin® has been used to treat over 230 000 HER2-positive breast cancer patients worldwide. 3

“HER2-positive breast cancer, which affects approximately one in four women with breast cancer, demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.1,2, says Singh.

For women who have early-stage breast cancer and are HER2-positive, Herceptin® can be used in combination with other treatments such as chemotherapy, or after surgery, to reduce the risk of the cancer recurring.1

According to an editorial in the New England Journal of Medicine (NEJM), Herceptin provides the best chance of being cured when used as early as possible in the course of the disease for women with HER2-positive early breast cancer. 8

Dr.D. Moodley, a Medical Oncologist at the Donald Gordon Medical Centre in Johannesburg agrees, “Herceptin® has been scientifically proven to reduce the recurrence of highly-aggressive HER2-positive breast cancer and significantly boosts the chances of disease-free survival among women with HER2-positive breast cancer.”

“We are obviously very pleased that we now have approval of the drug for use in women with all stages of the disease.”

Breast Cancer patients wishing to learn more about HER2-positive breast cancer can visit www.her2.co.za.

References

1.Piccart-Gebhart MJ, Proctor M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72.

2.Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002.

3. BCIRG 006 (international), Presentation, San Antonio Breast Cancer Conference, 2006

4.Edward H. Romond, MD., Edith A. Perez, MD., John Bryant, Ph.D, et al. Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84.

5.Roche data on file

6.World Health Organization, 2000.

7.Extra JM, Cognetti F, Maraninchi D et al. Long-term survival demonstrated with trastuzumab plus docetaxel: 24-month data from a randomised trial (M77001) in HER2-positive metastatic breast cancer. Abstract #555, American Society for Clinical Oncology (ASCO) Annual Meeting 2005.

8.Hortobagyi G, MD., Trastuzumab in the Treatment of Breast Cancer. N Engl J Med. 2005 Oct 20;353(16):1634-84.