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news.The FDA has approved Genentech's Herceptin, as part of a combined treatment regimen with other chemotherapies for breast cancer in women who have undergone surgery.
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Herceptin will be combined with doxorubicin, cyclophosphamide and paclitaxel to treat HER-2 positive early-stage breast cancer patients who have had initial treatment with the goal of reducing the risk of cancer recurrence.
In 1998 Herceptin was approved as a treatment for women with breast cancer who generated the protein HER-2 and whose cancer had spread to other parts of their body.
The FDA approval was based on data from an interim joint analysis from two phase III clinical trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence by 52% in women with HER-2 positive breast cancer, compared to those patients who received standard adjuvant therapy alone.
“This is the largest improvement in outcome for any group of women with breast cancer in 25 years,” said Edward Romond, professor of medicine, Division of Hematology/Oncology at the University of Kentucky.
After three-and-a-half years in the study, 87% of women treated with Herceptin plus chemotherapy were disease free, compared to 71% of women treated with chemotherapy alone.