03 Apr 2008

Anti-breast cancer drug approved

South African women diagnosed with HER2-positive breast cancer – considered one of the most aggressive forms of breast cancer – will now have access to life-saving HER2-targeted intravenous (IV) therapy, targeted for HER2-positive early breast cancer, no matter what stage of the disease they are at.

The approval of this drug in South Africa by the Medicines Control Council (MCC) comes in less than 18 months of the European Commission’s approval of the drug for use in patients with early-stage HER2-positive breast cancer in May 2006.

The approval by the MCC means that this life-saving treatment option can be extended to patients with all stages of HER2-positive early breast cancer.

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

For women who have early-stage breast cancer and are HER2-positive, HER2-targeted IV targeted therapy can be used in combination with other treatments such as chemotherapy, or after surgery, to reduce the risk of the cancer coming back.

According to Dr Ashika Singh, Head of Medical at Roche Products (Pty) Ltd in Johannesburg, the international HERA (HERceptin Adjuvant) study, which is one of the largest adjuvant studies ever carried out among breast cancer patients, with some 5 100 HER2-positive patients enrolled for the trial at 480 sites in 39 countries across the world, shows impressive results.

Reduces reoccurrence of cancer
“The study showed that HER2-targeted IV therapy, following standard chemotherapy, significantly reduces the risk of HER2-positive breast cancer recurring by approximately 50% compared to chemotherapy alone.1 Similarly, remarkable benefits have also been seen in three other major global and US studies.3,4 ,” says Singh.

According to an editorial in the New England Journal of Medicine (NEJM), HER2-targeted IV therapy 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. 6

Dr Devon Moodley, a Medical Oncologist at the Donald Gordon Medical Centre in Johannesburg agrees, “While most breast cancers are HER2-negative, an alarming one in four women with breast cancer will have HER2-positive tumours. HER2-positive tumours are fast-growing and the likelihood of the cancer coming back is greater because HER2-positive breast cancer usually responds less favourably to chemotherapy, making it one of the most aggressive types of breast cancer.”

“However, with medical advances, being diagnosed with HER2-positive breast cancer no longer needs to be a death sentence. HER2-targeted IV therapy provides women with HER2-positive breast cancer with a viable and effective treatment option that can reduce the chances of the cancer recurring and boost their chances of disease-free survival.”

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